Paris (ots/PRNewswire) – Bristol-Myers Squibb announced today that BARACLUDE(R) (entecavir) has been approved by the European Commission on February 28th 2011 to treat chronic hepatitis B (CHB) in adult patients with evidence of decompensated liver disease. BARACLUDE(r) was already approved in Europe in June 2006 for use in adult patients with CHB with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. this approval grants BARACLUDE(r) marketing authorisation in the 27 countries of the European Union. In the U.S., the Food and Drug Administration (FDA) approved the decompensated indication for BARACLUDE(r) in October 2010. Decompensated liver disease is characterised by failure of the liver to maintain adequate function, usually due to severe scarring, leading to fibrosis and/or cirrhosis caused by chronic liver inflammation.[1] It represents the end stage of hepatitis. Natural history data demonstrate that up to 40% of patients with CHB develop cirrhosis over their lifetimes, at a reported rate of 2-6% per year.[1] among CHB patients with cirrhosis, 3-5% per year progress to decompensated cirrhosis and 2-5% develop hepatocellular carcinoma (HCC).[2,3] Currently, the median survival rate in decompensated patients is two to three years, with only 28% of patients surviving for more than five years.[1,4] once liver disease progresses to the decompenstated stage, a liver transplant is often necessary. “The approval of this additional indication is an important milestone for CHB patients living with decompensated liver disease, a difficult to treat population whose mortality rates are high,” said Professor Jorg Petersen. “The data used to support this indication shows that BARACLUDE(r) is efficacious in treating decompensated patients.” this approval is based on a randomised, open-label, multi-centre study (ETV-048) that compared the efficacy&safety of BARACLUDE(r) (1.0 mg once daily) with adefovir (10.0 mg once daily) administered in patients with HBeAg positive or negative CHB who had evidence of liver decompensation. Data demonstrated that BARACLUDE(r) showed greater viral suppression compared to adefovir at 24 and 48 weeks following treatment initiation. At 48 weeks, 57% (57/100) of patients treated with BARACLUDE(r) achieved an undetectable viral load (less than or equal to 300 copies/ml) compared to 20% (18/91) of patients on adefovir. ETV-048 Study Results The 048 study evaluated 191 patients who were either HBeAG-positive or HBeAG-negative. Patients were either treatment-naive or had been previously treated excluding pre-treatment with BARACLUDE(r), adefovir or tenofovir. Patients were randomised to receive BARACLUDE(r) (1.0 mg once daily) or adefovir (10.0 mg once daily) and were analysed through 48 weeks. Baseline demographics were similar for both groups. Importantly, at baseline, patients had a mean CPT (child-pugh score) of 8.81 in the BARACLUDE(r) arm and 8.35 in the adefovir arm, and the mean MELD (Model for end stage Liver Disease) score was 17.1 and 15.3, respectively. Both of these parameters measure the severity of hepatic decompensation. The mean age of the study population was 52 years and the majority of the subjects were male (74%) and either Asian (54%) or Caucasian (33%).[5] In the primary efficacy endpoint of mean change from baseline in serum HBV DNA at Week 24, BARACLUDE(r) was superior to adefovir (-4.48 versus -3.40; p < 0.0001). Secondary efficacy endpoints included mean change from baseline in serum HBV DNA at Week 48 (-4.66 in the BARACLUDE(r) arm and -3.90 in the adefovir arm). In addition a greater proportion of patients on BARACLUDE(r) achieved an undetectable viral load compared to patients on adefovir at 48 weeks: 57% (57/100) versus 20% (18/91), respectively. Also patients on the BARACLUDE(r) arm decreased their MELD score from baseline by -2.6% versus -1.7% in the adefovir arm at Week 48, even though baseline MELD score had been higher with 17.1 for BARACLUDE(r) than 15.3 for adefovir. Further the normalization of ALT (Alanine Aminotransferase enzyme) was achieved to a higher proportion in the BARACLUDE(r)-treated patients (less than or equal to 1 x Upper Limit of Normal) at Week 48 [63% (49/78)] compared with adefovir-treated patients [46% (33/71)]. The time to onset of HCC or death was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with BARACLUDE(r) and adefovir, respectively; and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for BARACLUDE(r) and adefovir, respectively. BARACLUDE(r) was generally well tolerated and safety results were comparable between the treatment groups and consistent with those previously reported for a population with decompensated liver disease. Serious adverse events occurred in 69% of the BARACLUDE(r) patients and 66% of the adefovirpatientsand discontinuations due to adverse events occurred in 7% of the Baraclude patients and 6 % of the adefovir patients.[5] Important Information about BARACLUDE(r) Discovered at Bristol-Myers Squibb, BARACLUDE(r) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: – Compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. – Decompensated liver disease. a higher rate of serious hepatic adverse events (regardless of causality) has been observed in patients with decompensated liver disease, in particular in those with Child-Turcotte-Pugh (CTP) class C disease, compared with rates in patients with compensated liver function. In addition, patients with decompensated liver disease may be at higher risk for lactic acidosis and specific renal adverse events such as hepatorenal syndrome. Clinical and laboratory parameters should be closely monitored in this patient population. * for full prescribing information for BARACLUDE(r), please consult the Summary of Product Characteristics. about Chronic Hepatitis B (CHB) Chronic hepatitis B is a serious global health issue. Worldwide, more than 2 billion people have been in contact with the hepatitis B virus and approximately 350 million people are chronically infected.[6] about Decompensated Liver Disease Decompensated liver disease is characterised by failure of the liver to maintain adequate function, often due to severe scarring leading to fibrosis and/or cirrhosis caused by chronic liver inflammation.[1] Symptoms of liver decompensation can include but are not limited to: jaundice (yellowing of the skin or eyes), ascites (swollen abdomen from abnormal accumulation of fluid), oesophageal varices (distorted blood vessels that may cause potentially fatal bleeding), and hepatic encephalopathy ( neuropsychiatric abnormality resulting in personality changes, intellectual impairment and reduced levels of consciousness).[1] about Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. BARACLUDE(R) (entecavir) is a registered trademark of Bristol-Myers Squibb Company. References 1. D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J. Hepatol. 2006; 44: 217-31. 2. Chu C-M and Liaw Y-F. Hepatitis B virus-related cirrhosis: Natural history and treatment. Seminars in Liver Disease 2006;26(2):142-152. 3. Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: Incidence and risk factors. Gastroenterology 2004;127(5 Suppl 1):S35-S50. 4. Fattovich G, Pantalena M, Zagni I et al. Effect of hepatitis B and C virus infections on the natural history of compensated cirrhosis: a cohort study of 297 patients. Am. J. Gastroenterol. 2002; 97: 2886-95. 5. Y. Liaw, et al. Efficacy and Safety of Entecavir versus Adefovir in Chronic Hepatitis B Patients with Evidence of Hepatic Decompensation. Abstract and Poster 442. AASLD 2009. 6. World Helath Organization Web site. Fact sheet N- 204. who.int/mediacentre/factsheets/fs204/en/. Accessed 3 December 2010.ots Originaltext: Bristol-Myers Squibb GmbH&Co.KG aA Im Internet recherchierbar: presseportal.deContact: Contact: Media: Annie Simond, office: +33-1-58-83-65-66,© 2011 news aktuell

Cerebroad Cinnarizine 25mg 250Tablets Cerebral arterio sclerosis symptoms MigrainePackage : 25×10 tablets.(250 tablets)Cinnarizine 25 mg is used for treatment of Labyrinthopaty, vascular vestibulopathy, Meniere?€?s disease; prevention and treatment of kinesis.Cinnarizine 25 mg Dosage and administration: – Cinnarizine 25 mg is used orally, before nutrition. In prevention of kinesis – 25 mg, a half to one hour before the traveling, and after that – 25 mg each 6 hours. For the treatment of patients with labyrinthopaty, vestibular disorders,and Meniere?€?s disease the dose is 75 mg, given three times daily. Maximal dose in adults is 225 mg/24 h. In order to achieve an optimal therapeutic effect Cinnarizine 25 mg should be used for several months.In elderly patients the treatment should be started with low doses (average ?? of the recommended dose), with gradually increase of the daily dose until the expected therapeutic effect is achieved.In children recommended daily dose is average of the daily dose in adults.Contraindications of Cinnarizine 25 mg : Hypersensitivity to the preparation; pregnancy and lactation.Cinnarizine 25 mg Special warnings and precautions: Cinnarizine 25 mg should be used with care in: adult patients, children, patients with family history or clinical manifestations of extrapyramidal disorders. In persons with hypotension during the treatment the blood pressure shouldbe monitored. In long-term treatment with Cinnarizin hematology variables, iver and renal laboratory tests should be monitored. Cinnarizine 25 mg may cause a somnolence, which reduces the attention and disturbs the driving capabilities,particularly in the beginning of the treatment. This requires special care when using the medicine in drivers and machinery operating persons.Cinnarizine 25 mg Drug interactions: Cinnarizine 25 mg may potentiate the effects of the antidepressants and alcohol.Antiacide medicines and H2-blockers accelerate the resorption of the preparation, reducing acidity of the stomach fluid.Nootrope agents and vasodilators increase Cinnarizine 25 mg effects.Cinnarizine 25 mg Adverse reactions: at the onset of the treatment the most frequent adverse reactions are:somnolence, abdominal pain and discomfort, which usually are transitory and resolve after the dose adjustment.Hypersensitivity reactions usually affect the skin. Cinnarizine 25 mg may intensify the trend to hypotension reactions orpreexistent hypotension, xerostomia, appetite increase. The most serious adverse reactions are extrapyramidal disorders (tremor, disorientation, balance disorders), including Parkinson?€?s syndrome. Cinnarizine 25 mg may cause false doping-positivereactions in sportsmen. due to its antihistamine effect Cinnarizin may lead to false – negative result in intradermal hypersensitivity testing. In this reason the treatment with Cinnarizine 25 mg should be discontinued at least 4 days before the testing.Pharmacological mechanisms: Cinnarizine 25 mg improves the brain and peripheral microcirculation, antagonizing vascular effects of the endogenous monoamines and oligopeptides, and blocking the calcium influx in the myocytes of the vessel wall. Cinnarizine 25 mg possesses a high affinity to the vessel smooth muscle cells in the brain. Cinnarizine 25 mg reduces the erythrocyte deformity and improves rheology of the blood. Improves the cell resistance to hypoxia. Cinnarizin has no cardiodepressive effect. Reduces nystagmus and other vestibular disorders, reduces the labyrinth irritability. Exerts certain antihystamine action.Generic name: Cinnarizine 25 mg

Press Release Source: Tibotec Therapeutics on Monday December 13, 2010, 6:37 pm EST

TITUSVILLE, N.J., Dec. 13, 2010 /PRNewswire/ — Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of PREZISTA® (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMs).(1)  

The revised dosing recommendation extends the same dosing already approved for treatment-naive patients – PREZISTA, co-administered with ritonavir (in combination with other antiretroviral agents and with food, once-daily (800/100 mg) – to treatment-experienced patients with no DRV RAMs. the previously approved dosing recommendation for PREZISTA/ritonavir in treatment-experienced patients (patients who have taken HIV medications in the past) was PREZISTA/ritonavir 600/100 mg twice daily.  

For antiretroviral treatment-experienced patients, genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.

The approval of this revision is based on 48-week data from the ODIN (Once-daily Darunavir In treatment-experieNced patients) study. ODIN evaluated the efficacy and safety of PREZISTA/ritonavir once daily vs. PREZISTA/ritonavir twice daily for the treatment of HIV-1 in treatment-experienced adult patients with no DRV RAMs (i.e., V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, or L89V).

“With this once-daily dosing recommendation, boosted PREZISTA is now a viable option for more treatment-experienced patients,” said Glenn Mattes, president, Tibotec Therapeutics. “This approval reflects Tibotec’s ongoing commitment to optimizing dosing strategies for HIV patients.”  

Data from the Phase 3b ODIN study were presented earlier this year at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco. the study achieved its primary objective of demonstrating non-inferiority of PREZISTA/ritonavir once daily compared with twice daily.

PREZISTA Indication: Adults

PREZISTA, co-administered with ritonavir and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from two controlled, Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients, and two controlled, Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA/ritonavir:

• Treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/ritonavir.

• The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response.

About the ODIN Study

ODIN is a Phase 3b, randomized, open-label study that compared the efficacy, safety, and tolerability of PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily at week 48 in 590 treatment-experienced HIV-1-infected adult patients with no DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V). Patients had HIV-1 RNA greater than 1,000 copies/mL and CD4 count greater than 50 cells/mm(3), and received a stable antiretroviral therapy regimen for greater than or equal to 12 weeks at screening. Patients received either once-daily (n=294) or twice-daily (n=296) PREZISTA/ritonavir plus optimized background regimen. the primary objective of the study was to demonstrate non-inferiority of PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily in confirmed virologic response (HIV-1 RNA less than 50 copies/mL [intent-to-treat/time-to-loss of virologic response; ITT-TLOVR]) at Week 48.

Important Safety Information

PREZISTA does not cure HIV-1 infection or AIDS, and does not prevent passing HIV-1 to others.

Drug Interactions

• Coadministration of PREZISTA/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, or simvastatin)

• Coadministration of PREZISTA/ritonavir is also contraindicated with rifampin and products containing St. John’s wort (Hypericum perforatum) because this may cause significant decrease in plasma concentration of darunavir, resulting in loss of therapeutic effect and development of resistance

• Coadministration is not recommended with indinavir, lopinavir/ritonavir, saquinavir, and pravastatin

• Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/ritonavir.

• This list of potential drug interactions is not complete.

Warnings & Precautions

• PREZISTA must be coadministered with ritonavir and food to achieve the desired antiviral effect. Failure to administer PREZISTA with ritonavir and food may result in a loss of efficacy of darunavir. Please refer to ritonavir prescribing information for additional information on precautionary measures

• Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/ritonavir. during the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/ritonavir. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse events

Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/ritonavir therapy has not been established

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA/ritonavir treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/ritonavir should prompt consideration of interruption or discontinuation of treatment

• Severe Skin Reactions:  Severe skin reactions (0.4%), accompanied by fever and/or elevations of transaminases in some cases, Stevens-Johnson Syndrome (
  ]]> http://symptomadvice.com/fda-approves-prezista%c2%aeritonavir-once-daily-dosing-for-hiv-1-treatment-experienced-adults-with-no-darunavir-resistance-associated-mutations/feed/ 0 http://symptomadvice.com/longer-term-phase-iii-data-show-novartis-drug-tasigna%c2%ae-continues-to-surpass-glivec%c2%ae-in-slowing-disease-progression-in-patients-with-newly-diagnosed-cml/ http://symptomadvice.com/longer-term-phase-iii-data-show-novartis-drug-tasigna%c2%ae-continues-to-surpass-glivec%c2%ae-in-slowing-disease-progression-in-patients-with-newly-diagnosed-cml/#comments Wed, 22 Dec 2010 07:51:19 +0000 Symptom Advice http://symptomadvice.com/longer-term-phase-iii-data-show-novartis-drug-tasigna%c2%ae-continues-to-surpass-glivec%c2%ae-in-slowing-disease-progression-in-patients-with-newly-diagnosed-cml/

  

  Novartis International AG /Longer-term Phase III data show Novartis drug Tasigna® continues to surpass Glivec® in slowing disease progression in patients with newly diagnosed CML Processed and transmitted by Thomson Reuters.the issuer is solely responsible for the content of this announcement.

  * Fewer patients taking Tasigna for Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase progressed to advanced stages of the disease * 24-month analysis confirms Tasigna induces deeper and more durable cytogenetic and molecular responses * Tasigna now approved in the US and Switzerland for this indication; regulatory submissions under review in EU, Japan and other countries worldwide

  Basel, December 6, 2010 – Novartis announced today 24-month data showing thatTasigna(®) (nilotinib) continues to surpass Glivec(®) (imatinib)* in thetreatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase[1]. these new data, from the first Phase III comparison of the two oral therapies as initialtreatment for this blood cancer, were presented at the 52(nd) Annual Meeting andExposition of the American Society of Hematology (ASH) in Orlando, Florida.

  With this longer-term follow-up at 24 months, first-line treatment with Tasignaat 300 mg twice daily was found to result in a lower incidence of progression toaccelerated phase and blast crisis, compared to the standard approved dose ofGlivec 400 mg once daily. Patients receiving Tasigna also had a lower incidenceof suboptimal response and treatment failure as defined by study criteria[1].

  These data also showed that Tasigna induced deeper and more durable completecytogenetic response (CCyR) and major molecular response (MMR) compared toGlivec, as well as a significantly higher rate of an even deeper response – atrace amount of 0.0032% or less of the Bcr-Abl protein that causes Ph+ CML, which is considered a complete molecular response (CMR)[1]. Fewer patientstaking Tasigna in the study discontinued treatment due to adverse eventscompared to Glivec[1]. Tasigna and Glivec were generally well tolerated.

  “These 24-month Phase III data extend the evidence of clinical benefit for newlydiagnosed patients with chronic phase Ph+ CML treated with Tasigna, compared toGlivec, ” said Timothy P. Hughes, MD, ENESTnd study investigator and ClinicalProfessor at the University of Adelaide, Australia. “Now we can begin toevaluate the long-term treatment outcomes of patients who achieve and maintaindeep reductions in Bcr-Abl on Tasigna.”

  Rates of MMR and CCyR remain statistically higher for Tasigna versus Glivec atthe 24-month minimum follow-up. MMR was achieved by 71% of patients takingTasigna 300 mg twice daily and 67% of patients taking Tasigna 400 mg twicedaily, compared to 44% of patients taking Glivec by 24 months. Durable MMR rateswere statistically significantly higher in the Tasigna 300 mg twice daily andTasigna 400 mg twice daily arms compared to Glivec 400 mg once daily (42%, 39%and 21% respectively). Significantly more patients achieved CCyR in the Tasigna300 mg and 400 mg arms compared to the Glivec arm at 87% and 85% vs. 77%respectively by 24 months.

  The US Food and Drug Administration (FDA) and Swissmedic have approved Tasignain this first-line indication. In September, Novartis received a positiveopinion from the Committee for Medicinal Products for Human Use (CHMP)recommending European Commission approval for Tasigna for this indication.Regulatory submissions are under review in the European Union, Japan and othercountries worldwide.

  This year, Novartis also began a collaboration with molecular diagnosticscompany Cepheid to develop a new FDA cleared/approved Bcr-Abl test, whichadheres to the International Scale. the goal of the collaboration is to helpdoctors more reliably monitor Ph+ CML patients. Cepheid and Novartis also willdevelop a next generation test, which is expected to enable even more sensitivetesting, indicating the depth of a patient´s response to tyrosine kinaseinhibitors, including Tasigna and Glivec. Currently there are no FDAcleared/approved tests to monitor for Bcr-Abl.

  “The creation and introduction of Glivec revolutionized the treatment of Ph+ CMLby substantially improving overall survival rates for patients, ” said HervéHoppenot, President, Novartis Oncology. “We are encouraged by the ongoingclinical development of Tasigna as a new treatment showing that at 24 months itcontinues to surpass Glivec in slowing disease progression in patients withnewly diagnosed chronic phase Ph+ CML.”

  Another study will be presented at this year´s annual ASH meeting which providesfurther support for the use of Tasigna in patients with newly diagnosed Ph+ CML.the Gruppo Italiano Malattie Ematologiche dell´Adulto (GIMEMA) study, anongoing, open-label, single-stage, multicenter Phase II clinical trial, will bepresented on Monday, December 6, 2010[2].

  ENESTnd Study DetailsThe clinical trial, ENESTnd (Evaluating Nilotinib Efficacy and Safety inClinical Trials of Newly Diagnosed Ph+ CML Patients), is a Phase III randomized, open-label, multicenter trial comparing the efficacy and safety of Tasignaversus Glivec in adult patients with newly diagnosed Ph+ CML in chronicphase[1]. it is the largest global randomized comparison of two oral therapiesever conducted in newly diagnosed Ph+ CML patients.

  ENESTnd is being conducted at 217 global sites with 846 patients enrolled.Patients were randomized to receive Tasigna 300 mg twice daily (n = 282), Tasigna 400 mg twice daily (n = 281) or Glivec 400 mg once daily (n = 283). Theprimary endpoint was MMR at 12 months; the key secondary endpoint was durableMMR at 24 months (patients having MMR when evaluated at both 12 and 24months)[1]. MMR was defined in the study as reduction in the level of theabnormal Bcr-Abl gene to less than or equal to 0.1% of the pretreatment levelbased on an internationally agreed standard(1). Planned follow-up is for fiveyears. Patients on the Glivec treatment arm who had suboptimal response ortreatment failure were allowed to escalate dose and/or switch to Tasigna via aprotocol extension. these data, presented at ASH, were the 24-month minimumfollow-up.

  Results showed that fewer patients progressed to accelerated phase or blastcrisis while on treatment with Tasigna at 300 mg twice daily (n = 2) and 400 mgtwice daily (n = 3) versus Glivec at 400 mg once daily (n = 12)[1] with 24months of minimum follow-up demonstrating a significant improvement in diseasecontrol.

  These data also showed that nearly three times more patients taking Tasigna 300mg twice daily achieved CMR – defined as a trace amount of 0.0032% or less ofthe Bcr-Abl protein that causes Ph+ CML – with Tasigna 300 mg twice daily (n =70) than with Glivec (n = 25) by 24-months[1].

  All patients had a minimum of 24 months of treatment or discontinued early; themedian follow-up was 25 months. overall, 75%, 78% and 68% of patients remainedin the study on Tasigna 300 mg twice daily, Tasigna 400 mg twice daily andGlivec 400 mg once daily, respectively[1].

  Both Tasigna and Glivec were generally well tolerated overall. Rates ofdiscontinuation due to adverse events or laboratory abnormalities were 9% forTasigna 300 mg twice daily, 13% for Tasigna 400 mg twice daily and 11% forGlivec 400 mg once daily[1]. no patients treated with Tasigna in the study hadprolongation of QT interval >500 milliseconds[1]. no sudden deaths occurred inany of the treatment arms[1].

  About Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)Chronic myeloid leukemia is a disease in which the body produces cancerous whiteblood cells. Almost all patients with CML have an abnormality known as thePhiladelphia chromosome, which produces a protein called Bcr-Abl. Bcr-Abl causesmalignant white blood cells to proliferate[3]. Worldwide, CML is responsible forapproximately 10% to 15% of all adult cases of leukemia[4], with an incidence ofone to two cases per 100,000 people per year[5].

  About Tasigna[6]()Tasigna has been approved in over 85 countries for the treatment of chronicphase and accelerated phase Ph+ CML in adult patients resistant or intolerant toat least one prior therapy, including Glivec. the effectiveness of Tasigna forthis indication is based on confirmed hematologic and unconfirmed cytogeneticresponse rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

  Tasigna is not approved in the EU for the treatment of newly diagnosed Ph+ CML-CP.

  Tasigna important Safety InformationTasigna should be taken twice daily at an interval of approximately 12 hoursapart and must not be taken with food. no food should be consumed for two hoursbefore the dose and for at least one hour after the dose. Avoid grapefruit juiceand other foods that are known to inhibit CYP3A4.

  Tasigna should not be used in patients who are hypersensitive to nilotinib orany of the excipients.

  Treatment with Tasigna has been associated with hematological side effects, suchas thrombocytopenia, neutropenia and anemia which was generally reversible andusually managed by withholding Tasigna temporarily or dose reduction. Completeblood counts should be performed every two weeks for the first two months andthen monthly thereafter as clinically indicated.

  Tasigna should be used with caution in patients with uncontrolled or significantcardiac disease (e.g., recent heart attack, congestive heart failure, unstableangina or clinically significant bradycardia), as well as in patients who haveor may develop prolongation of QTc. these include patients with abnormally lowpotassium or magnesium levels, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicines or other drugs that may lead to QTprolongation. Low levels of potassium or magnesium must be corrected prior toTasigna administration. Close monitoring for an effect on the QTc interval isadvisable and a baseline electrocardiography is recommended prior to initiatingtherapy with Tasigna and as clinically indicated. Uncommon cases (0.1 to 1%) ofsudden death have been reported in clinical studies in patients with significantrisk factors.

  Tasigna should be used with caution in patients with liver impairment, inpatients with a history of pancreatitis and in patients with total gastrectomy.Patients with rare hereditary problems of galactose intolerance, severe lactasedeficiency or glucose-galactose malabsorption should not use Tasigna. Tasignashould not be used during pregnancy unless clearly necessary and breast feedingis not recommended during treatment.

  The most frequent Grade 3 or 4 adverse events for Tasigna were primarilyhematological in nature and included neutropenia and thrombocytopenia.Elevations seen in bilirubin, liver function tests, lipase enzymes and bloodsugar were mostly transient and resolved over time. these cases were easilymanaged and rarely led to discontinuation of treatment. Pancreatitis wasreported in less than 1% of cases. the most frequent non-hematologic drug-related adverse events were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, constipation and diarrhea. most of these adverse events were mild tomoderate in severity.

  About Glivec[7]Glivec is approved in more than 90 countries, including the US, EU and Japan, for the treatment of all phases of Ph+ CML. Glivec is also approved in the US, EU and other countries for the treatment of patients with Kit (CD117)-positivegastrointestinal tumors (GIST), which cannot be surgically removed and/or havealready spread to other parts of the body (metastasized). In the US and EU, Glivec is now approved for the post-surgery treatment of adult patientsfollowing complete surgical removal of Kit (CD117)-positive gastrointestinalstromal tumors. In the EU, Glivec is also approved for the treatment of adultpatients with newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) incombination with chemotherapy and as a single agent for patients with relapsedor refractory Ph+ ALL. Glivec is also approved for the treatment of adultpatients with unresectable, recurrent and/or metastatic dermatofibrosarcomaprotuberans (DFSP) who are not eligible for surgery. Glivec is also approved forthe treatment of patients with myelodysplastic/myeloproliferative diseases(MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chroniceosinophilic leukemia (HES/CEL).

  The effectiveness of Glivec is based on overall hematological and cytogeneticresponse rates and progression-free survival in CML, on hematological andcytogenetic response rates in Ph+ ALL, MDS/MPD, on hematological response ratesin systemic mastocytosis, HES/CEL, on objective response rates and progression-free survival in unresectable and/or metastatic GIST, on recurrence freesurvival in adjuvant GIST and on objective response rates in DFSP. Increasedsurvival in controlled trials has been demonstrated only in newly diagnosedchronic phase CML and GIST.

  Not all indications are available in every country.

  Glivec important Safety InformationThe majority of patients treated with Glivec in clinical trials experiencedadverse events at some time. most events were of mild to moderate grade andtreatment discontinuation was not necessary in the majority of cases.

  The safety profile of Glivec was similar in all indications. the most commonside effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema and fluid retention, as well as neutropenia, thrombocytopenia and anemia.Glivec was generally well tolerated in all of the studies that were performed, either as monotherapy or in combination with chemotherapy, with the exception ofa transient liver toxicity in the form of transaminase elevation andhyperbilirubinemia observed when Glivec was combined with high dosechemotherapy.

  Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepaticfailure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renalfailure, fluid retention, edema (including brain, eye, pericardium, abdomen andlung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumor hemorrhage/necrosis and hiposteonecrosis/avascular necrosis.

  Patients with cardiac disease or risk factors for cardiac failure should bemonitored carefully and any patient with signs or symptoms consistent withcardiac failure should be evaluated and treated. Cardiac screening should beconsidered in patients with HES/CEL, and patients with MDS/MPD with high levelof eosinophils (echocardiogram, serum troponin level).

  Glivec is contraindicated in patients with known hypersensitivity to imatinib orany of its excipients. Women of childbearing potential should be advised toavoid becoming pregnant while taking Glivec.

  DisclaimerThe foregoing release contains forward-looking statements that can be identifiedby terminology such as “under review, ” “expected, ” “goal, ” or similarexpressions, or by express or implied discussions regarding potential newindications or labeling for Tasigna or regarding potential future revenues fromTasigna or Glivec. You should not place undue reliance on these statements. Suchforward-looking statements reflect the current views of management regardingfuture events, and involve known and unknown risks, uncertainties and otherfactors that may cause actual results with Tasigna or Glivec to be materiallydifferent from any future results, performance or achievements expressed orimplied by such statements. There can be no guarantee that Tasigna will beapproved for any additional indications or labeling in any market. Nor can therebe any guarantee that Tasigna or Glivec will achieve any particular levels ofrevenue in the future. In particular, management´s expectations regardingTasigna and Glivec could be affected by, among other things, unexpectedregulatory actions or delays or government regulation generally;  unexpectedclinical trial results, including unexpected new clinical data and unexpectedadditional analysis of existing clinical data; the company´s ability to obtainor maintain patent or other proprietary intellectual property protection;competition in general; government, industry and general public pricingpressures; the impact that the foregoing factors could have on the valuesattributed to the Novartis Group´s assets and liabilities as recorded in theGroup´s consolidated balance sheet, and other risks and factors referred to inNovartis AG´s current Form 20-F on file with the US Securities and ExchangeCommission. should one or more of these risks or uncertainties materialize, orshould underlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected. Novartis isproviding the information in this press release as of this date and does notundertake any obligation to update any forward-looking statements contained inthis press release as a result of new information, future events or otherwise.

  About NovartisNovartis provides healthcare solutions that address the evolving needs ofpatients and societies. Focused solely on healthcare, Novartis offers adiversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools andconsumer health products. Novartis is the only company with leading positions inthese areas. In 2009, the Group´s continuing operations achieved net sales ofUSD 44.3 billion, while approximately USD 7.5 billion was invested in R&Dactivities throughout the Group. Headquartered in Basel, Switzerland, NovartisGroup companies employ approximately 100,000 full-time-equivalent associates andoperate in more than 140 countries around the world. For more information, please visitnovartis.com.

  Novartis is on Twitter. Sign up to follow @Novartis attwitter.com/novartis.

  *Known as Gleevec(®) (imatinib mesylate) tablets in the US, Canada and Israel.

  References 1. Hughes T, et al. ENESTnd Update: Continued Superiority of Nilotinib Versus Imatinib In Patients with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP). 52nd Annual Meeting of the American Society of Hematology. Abstract no. 207. December 6, 2010. 2. Rosti G, et al. Excellent Outcomes at 3 Years with Nilotinib 800 Mg Daily In Early Chronic Phase, Ph+ Chronic Myeloid Leukemia (CML): Results of a Phase 2 GIMEMA CML WP Clinical Trial. 52nd Annual Meeting of the American Society of Hematology. Abstract no. 359. December 6, 2010. 3. National Cancer Institute. General Information About Chronic Myelogenous Leukemia (PDQ). cancer.gov/cancertopics/pdq/treatment/CML/patient/. Accessed March 2009. 4. American Cancer Society.  Detailed Guide: CML. what are the key statistics about CML? (Sept 2008 revision) Available at: cancer.org/cancer/leukemia- chronicmyeloidcml/detailedguide/leukemia-chronic-myeloid-myelogenous-key- statistics.  Accessed April 2009. 5. Central European Leukemia Study Group. About CML. [Cited 2009 Jan 13] Available from: cml-info.com/de/healthcare-professionals/about- cml.html. 6. Tasigna (nilotinib) European Summary of Characteristics. Novartis AG. tasigna.com/en/tasigna-product-information.jsp#. 7. Glivec® (imatinib) prescribing information. Basel, Switzerland: Novartis International AG; March 2009.

  Novartis Media Relations

  Central media line : +41 61 324 2200

  Eric Althoff Amy Vinci Novartis Global Media Relations Novartis Oncology +41 61 324 7999 (direct) +1 862 778 6309 +41 79 593 4202 (mobile) amy.vinci@novartis.com

  For Novartis multimedia content, please visit thenewsmarket.com/Novartis.For questions about the site or required registration, pleasecontact:journalisthelp@thenewsmarket.com.

  Novartis Investor Relations

  Central phone: +41 61 324 7944

  Susanne Schaffert +41 61 324 3769 North America:

  Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433

  Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445

  Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456

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  Novartis International AGPostfach Basel

  WKN: 904278;ISIN: CH0012005267;

  Media Release (PDF): hugin.info/134323/R/1469242/406509.pdf

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