Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SUTENT? (sunitinib malate) as the first anti-VEGF therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide.1,2

“We are delighted that SUTENT has been granted approval by the FDA as an effective treatment option for individuals with pancreatic NET. This approval represents the third disease indication for SUTENT, which was approved by the FDA in 2006 for treatment of patients with advanced kidney cancer and imatinib-resistant or intolerant gastrointestinal stromal tumor (GIST),” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. “Pfizer is committed to improving the lives of those with cancer. This approval is good news for the physicians, patients and caregivers who have had limited treatment options for this rare and difficult-to-treat tumor.”

the FDA approval is based on data from the SUN 1111 pivotal Phase 3 trial that demonstrated SUTENT provided a clinically significant improvement in progression-free survival (PFS) compared to placebo (10.2 versus 5.4 months, p=0.000146) in this patient population.3 Treatment with SUTENT also yielded a statistically significant improvement in tumor response, with an objective response rate (ORR) of 9.3 percent (95% CI: 3.2, 15.4, p=0.0066). No objective responses were observed with placebo. in addition, while overall survival (OS) was not mature at the time of final analysis, nine deaths were observed in patients enrolled in the SUTENT arm versus 21 deaths in patients enrolled in the placebo arm.3,4

“This approval is welcome news for physicians who have struggled to find a treatment option that shows a substantial clinical benefit in treating advanced pancreatic NET,” said Dr. Eric Raymond, professor of medical oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France and principal investigator of the SUN 1111 Phase 3 trial. “Pancreatic NET is a highly vascular tumor, and as the first anti-VEGF therapy approved for this disease, SUTENT represents a treatment that attacks a key component of tumor growth.”

About the SUN 1111 Trial

SUN 1111 was a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 study (n=171) evaluating single-agent SUTENT in patients with unresectable pancreatic NET, characterized by cancer that could not be surgically removed. the primary endpoint was PFS. other endpoints included OS, ORR and safety. use of somatostatin analogs were allowed in the study.3

the approval of SUTENT in this patient population was based on FDA assessment of PFS observed in SUN 1111. Previously reported investigator-assessed data from the trial, published in the New England Journal of Medicine, showed SUTENT more than doubled median PFS compared with placebo (11.4 versus 5.5 months, p<0.0001), which was found to be consistent in a blinded, independent central review of scans from the study (12.6 versus 5.8 months, p=0.000015).4,5 in February 2009, the independent Data Monitoring Committee for the SUN 1111 trial recommended that randomization to the study be halted early in the interest of patient safety and based on the very strong likelihood that the study would meet its primary endpoint if continued to completion. This may have led to an overestimate of the magnitude of PFS effect.

SUTENT has been approved for advanced pancreatic NET in Europe and nine additional countries. SUTENT is also approved for both gastrointestinal stromal tumors (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced renal cell carcinoma (RCC) in over 100 countries and has been studied in over 10,000 patients in clinical trials. to date, with more than five years of experience, more than 100,000 patients have been treated with SUTENT worldwide.

About Pancreatic Neuroendocrine Tumors (Pancreatic NET)

Pancreatic NET is different from pancreatic adenocarcinoma, which account for about 95 percent of all pancreatic cancers.6 Pancreatic NET is a member of a broad group of cancers called neuroendocrine tumors, which arise from hormone-producing cells of the body.7,8 while neuroendocrine tumors that develop in the pancreas are known as pancreatic NET, those that arise in other areas of the body, including the lungs and gastrointestinal tract, are known as carcinoids.7 Pancreatic NET, which are mostly well-differentiated,9 account for approximately 22-28 percent of all neuroendocrine tumors.10,11 nearly 90 percent of patients with pancreatic NET are initially diagnosed with locally advanced or metastatic disease (cancer that has spread to other organs).12 for patients with pancreatic NET that has metastasized, prognosis is poor, with a survival of only 1-3 years,13 similar to that seen with metastatic breast cancer or metastatic colon cancer.14,15

About SUTENT(?) (sunitinib malate)

SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Important SUTENT(?) (sunitinib malate) Safety Information

Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. It is recommended to monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. SUTENT should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. SUTENT should not be restarted if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.

Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) and cardiac failure, including death, have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. Complete blood counts (CBCs) with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.

the most common adverse reactions in GIST, RCC and pancreatic NET clinical trials were diarrhea, fatigue, asthenia, nausea, mucositis/stomatitis, anorexia, vomiting, neutropenia, hypertension, dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin discoloration, hair color changes, altered taste and bleeding.

for more information on SUTENT, including full prescribing information for SUTENT (sunitinib malate), please visit pfizer.com [pfizer.com].

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. Pfizer Oncology has biologics and small molecules in clinical development and more than 100 clinical trials underway. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. for more information please visit Pfizer.com.

_________________________

1 Ramage JK, Davies AHG, Ardill et al. Guidelines for the management of gastroenteropancreatic neuroendocrine (including carcinoid) tumours. Gut. 2005;54:iv1-16

2 Halfdanarson TR, Rabe KG, Rubin J et al. Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Ann Oncol. 2008;19:1727-33.

3 SUTENT [Package Insert]. new York, NY: Pfizer, Inc. 2011.

4 Raymond E, et al. Sunitinib Malate for the Treatment of Pancreatic Neuroendocrine Tumors. N Engl J Med 2011; 334: 501-13.

5 ASCO GI Abstract #249. Evaluation of Progression Free Survival by Blinded Independent Central Review in Patients with Progressive, Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib or Placebo. E. Van Cutsem – Presenter. 8th Annual Gastrointestinal (GI) Cancers Symposium, San Francisco, CA, January 20-22, 2011.

6 American Cancer Society. What is cancer of the pancreas? available at: cancer.org/Cancer/PancreaticCancer/DetailedGuide/pancreatic-cancer-what-is-pancreatic-cancer. Accessed March 1, 2011

7 National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology – Neuroendocrine Tumors. Version 1.2011: National Comprehensive Cancer Network, Inc.; 2011.

8 Cancer.net. Neuroendocrine Tumor. available at: cancer.net/patient/Cancer+Types/Neuroendocrine+Tumor. Accessed may 6, 2011.

9 Choi I, Estecio M, et al. Hypomethylation of LINE-1 and Alu in well-differentiated neuroendocrine tumors (pancreatic endocrine tumors and carcinoid tumors). Modern Pathology. 2007; 20:802-810.

10 Pape UF, Berndt U, Muller-Nordhorn J et al. Prognostic factors for long-term outcome in gastroenteropancreatic neuroendocrine tumors. Endocrine-Related Cancers; 15: 1083-97, 2008.

11 Ter-Minassian M, Frauenhoffer CS, Hooshmand SM et al. Prospective analysis of clinical outcomes and prognostic factors in patients with Neuroendocrine tumors (NETs). ASCO Meeting Abstracts; Jun 14; 4044, 2010.

12 Yao JC, Hassan M, Phan A, et al. one hundred years after “Carcinoid”: epidemiology of and prognostic factors for Neuroendocrine tumors in 35,825 cases in the United States. J Clin ONcol; 26 (18): 3063-72, 2008.

13 Yao JC, et al. Population-based study of islet cell carcinoma. Ann Surg Oncol. 2007;14(12):3492-3500

14 Pal SK, et al “Lack of survival benefit in metastatic breast cancer with newer chemotherapy agents: the City of Hope cancer experience” ASCO Breast 2008; Abstract 95.

15 Kopetz S, Chang G, et al. Improved Survival in Metastatic Colorectal Cancer is associated with Adoption of Hepatic Resection and Improved Chemotherapy. J Clin Oncol. 2009; 7:3677-3683.

Pfizer Inc.Media:Chris Loder, 212-733-7897orInvestors:Jennifer Davis, 212-733-0717

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ATM Treatment Options: How to effectively treat the symptoms of TMJ

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When I was diagnosed with multiple sclerosis in 2001, the only treatment option I was given involved strong drugs with many undesirable side effects. I chose not to take the drugs. Since they do not claim to cure multiple sclerosis, I thought the side effects were not worth the risks.

Here are some of the most common multiple sclerosis drugs and their side effects:

Avonex, Betaseron, Copaxone are commonly reffered to as the ABC drugs. These are strong interferon drugs taken every other day or weekly by injection. side effects include depression, flu-like symptoms, liver, heart, blood, and thyroid problems, risk to pregnancy, seizures.

Tysabri increases your chances of getting a rare brain infection that usually causes death or severe disability. this infection is called progressive multifocal leukoencephalopathy (PMI). there is no known treatment, prevention, or cure for PMI. These side effects seem worse than the disease.

Patients today, more than ten years since my diagnosis, are still being pushed toward drug therapy only. my treatment option is a life long gluten-free diet. After being on the diet for a short time (i.e. months) all my multiple sclerosis symptoms were relieved and I was on my way to a complete recovery! Do the MS drugs have the same success? no.

Here are some of the most common side effects from a gluten-free diet: NONE.   

SOURCE: Corcept Therapeutics

  Mar 31, 2011 16:25 ET

MENLO PARK, CA–(Marketwire – March 31, 2011) – Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, today announced that it will submit its New Drug Application (NDA) for the use of CORLUX in Cushing’s Syndrome to the FDA the week of April 11, 2011.

“We are in the final stages of preparing our NDA submission and are on track to submit our application to the FDA within the next two weeks,” said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. ”We look forward to submitting our NDA for CORLUX to the FDA, and, if approved by the FDA, providing an important treatment option to patients suffering from Cushing’s Syndrome.” 

CORLUX in Cushing’s Syndrome Regulatory and Commercialization Update

The completion of the NDA submission is a critical milestone for Corcept on our path to making CORLUX available to Cushing’s Syndrome patients. Additional initiatives in support of this objective include the following:

• We plan to submit a request to the FDA for Priority Review along with our NDA submission. according to the FDA, “Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.” the FDA’s goal for completing a Priority Review is six months. the FDA will notify us within 45 days of our request whether our NDA has been assigned a Priority Review or a Standard Review (for which the FDA’s goal is a ten month review time).

• We expect that the FDA will notify us whether our NDA submission has been accepted for filing within 74 days of submission, which the FDA bases on their initial 60-day review of the completeness of our application.

• We expect to make detailed data from our Phase 3 trial of CORLUX in Cushing’s Syndrome available to the endocrinologists who treat the disorder at the Endocrine Society Annual Meeting (ENDO), June 4-7 in Boston.

• We are developing plans and engaging third-party vendors to support a commercial launch of CORLUX in the United States, if approved by the FDA.

About Cushing’s Syndrome

Endogenous Cushing’s Syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s Syndrome is an orphan indication which most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients in the United States. An estimated 20,000 patients in the United States have Cushing’s Syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s Syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About CORLUX

Corcept’s first-generation compound, CORLUX, also known as mifepristone, directly blocks the cortisol (GR-II) receptor and the progesterone (PR) receptor. Intellectual property protection is in place to protect important methods of use for CORLUX. Corcept retains worldwide rights to its intellectual property related to CORLUX.

About Corcept Therapeutics Incorporated

Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. the company has completed its Phase 3 study of CORLUX for the treatment of Cushing’s Syndrome, and has an ongoing Phase 3 study of CORLUX for the treatment of the psychotic features of psychotic depression. Corcept also has a Phase 2 program for CORT 108297 and an IND-enabling program for CORT 113083. both of these novel compounds are selective GR-II antagonists – compounds which block the effects of cortisol but not progesterone. Corcept has developed an extensive intellectual property portfolio that covers the use of GR-II antagonists in the treatment of a wide variety of psychiatric and metabolic disorders, including the prevention of weight gain caused by the use of antipsychotic medication, as well as composition of matter patents for our selective GR-II antagonists.

Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to Corcept’s clinical development and research programs, the timing of the NDA submission and introduction of CORLUX and future product candidates, including CORT 108297 and CORT 113083, estimates of the timing of enrollment or completion of our clinical trials and the anticipated results of those trials, the ability to create value from CORLUX or other future product candidates and our estimates regarding our capital requirements, spending plans and needs for additional financing. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. for example, there can be no assurances with respect to the cost, rate of spending, completion or success of clinical trials; financial projections may not be accurate; there can be no assurances that Corcept will pursue further activities with respect to the development of CORLUX, CORT 108297, CORT 113083 or any of its other selective GR-II antagonists. these and other risk factors are set forth in the Company’s SEC filings, all of which are available from our website (corcept.com) or from the SEC’s website (sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.

Public release date: 16-Mar-2011 [ | E-mail | Share ] Contact: Maryann Verrillomverrillo@SIRweb.org703-460-5572Society of Interventional Radiology

FAIRFAX, Va.?The Society of Interventional Radiology will present the latest research on treatments for individuals with chronic cerebrospinal venous insufficiency or CCSVI; liver and breast cancer; enlarged prostates; uterine fibroids, high blood pressure; and more at its 36th Annual Scientific Meeting March 26󈞋 at McCormick Place (West) in Chicago, Ill. The theme of the meeting is “IR Rising: Leading Image-guided Medicine,” chosen to reflect interventional radiology’s continued revolutionizing of modern medicine.

Highlights of embargoed key interventional radiology studies being presented are listed below. Illustrations and broadcast-quality footage are available for some stories; interviews with lead researchers can be arranged on request.

Interventional Radiology Treatment for CCSVI in MS Patients Advancing MS Research: a look at a Vein-opening Treatment about 500,000 people in the United States have MS generally thought of as an incurable, disabling autoimmune disease? in which a person’s body attacks its own cells. a new study explores an endovascular treatment used by interventional radiologists to widen the veins in the neck and chest to improve blood flow. will it encourage additional studies for its use as a treatment option for chronic cerebrospinal venous insufficiency or CCSVI in individuals with multiple sclerosis? such treatments could be transformative for patients. (Embargoed for release until Monday, March 28, 2011, at 8 a.m. Eastern) B-roll will be available.

Cancer Advances Busting Liver Cancer: Is an Interventional Radiology Treatment Safer and Life Extending? in the United States, 20,000 cases of primary liver cancer are diagnosed each year; for metastatic colon cancer, that number is 150,000 per year. Interventional radiologists have pioneered an intra-arterial treatment for those with liver cancer. a large multi-institutional study provides new information on the use of intra-arterial yttrium-90 radioembolization, which was introduced in 2000, to treat liver cancer. what does this tiny treatment mean for individuals with liver cancer? (Embargoed for release until Monday, March 28, 2011, at 8 a.m. Eastern)

Delaying the Growth and Spread Breast Cancer: Can Tumors be Kept Dormant? in the United States, a woman is diagnosed with breast cancer every three minutes, and one woman will die from the disease every 13 minutes. Once breast cancer metastases have been detected, current treatments (such as surgical resection or tumor removal) may be ineffective. a new study looks at delaying the growth and spread of breast cancer with innovative interventional radiology strategies. (Embargoed for release until Tuesday, March 29, 2011, at 8 a.m. Eastern)

New Science Helping Wounded Warriors: Can Technology Developed for Navy Submarines be used to Diagnose Stroke Quickly? From the invention of angioplasty and the catheter-delivered stent, which were both first used to treat peripheral arterial disease in the legs, to drug-coated stents, balloon angioplasty, ozone generators and radiofrequency ablation and clot-removing devices of today?interventional radiologists have continued to shape and change the medical landscape and improve patient care. Stroke is the third leading cause of death in the United States and the leading cause of disability. again, interventional radiologists are at the forefront of new medicine with naval sonar technology that may offer a new paradigm for the detection, diagnosis and monitoring of stroke?especially when it comes to saving soldiers’ lives. Can this benefit other areas of acute care, such as high-risk surgeries? (Embargoed for release until Tuesday, March 29, 2011, at 8 a.m. Eastern)

Examining Radiation Safety: what if a Pre-administered Mix provided Protection against DNA damage? CT scans, mammograms and other medical imaging techniques are important diagnostic tools; however, safety and cell damage are legitimate concerns. Interventional radiologists remain at the forefront of radiation safety with a study that looks at reducing DNA injury. what if a specific formula mix helped patients?along with interventional and diagnostic radiologists, X-ray technologists and others who have occupational exposure? (Embargoed for release until Tuesday, March 29, 2011, at 8 a.m. Eastern)

DVT Awareness Learning the “Plane” Truth about Economy Class Syndrome: know the Risk Factors for DVT, Post-thrombotic Syndrome, Pulmonary Embolism in the United States alone, nearly 2 million new cases of deep vein thrombosis or DVT occur each year, and 600,000 people with the condition are admitted to hospitals. during DVT Awareness Month, the public should recognize the risk factors for deep vein thrombosis?it’s not just from extended plane rides. in adults and children, DVT can lead to pulmonary embolism, post-thrombotic syndrome, permanent damage to the leg and even death. Interventional radiologists, doctors at the forefront of research into minimally invasive methods to treat DVT and its complications, are addressing these conditions with new techniques that are faster, safer and extremely effective at not only treating?but destroying?the clot. (Embargoed for release until Monday, March 28, 2011, at 8 a.m. Eastern) B-roll and medical illustrations are available.

Men’s Health Treating Enlarged Prostates: No Scalpel Necessary all men will have enlarged prostates if they live long enough. An estimated 19 million men in the United States have benign prostatic hyperplasia, characterized by urinary frequency, urgency, passing urine more often (particularly at night), weakened stream and incomplete bladder emptying. find out more about how a new interventional radiology treatment that blocks blood supply to a man’s enlarged prostate compares to transurethral resection of the prostate (or TURP surgery), which is considered the current gold standard treatment. (Embargoed for release until Tuesday, March 29, 2011, at 8 a.m. Eastern)

Women’s Health Reducing Fibroid-Related Urinary Symptoms: An Outstanding Treatment choice Available Twenty to 40 percent of American women 35 and older have uterine fibroids, benign tumors in the uterus that can cause prolonged, heavy menstrual bleeding that can be severe enough to cause anemia or require transfusion, disabling pelvic pain and pressure and urinary frequency. Women’s urinary symptoms may be put in the background and not addressed initially. a new study provides first results on an effective minimally invasive treatment to control and relieve many lower urinary tract problems. (Embargoed for release until Tuesday, March 29, 2011, at 8 a.m. Eastern) B-roll and medical illustrations are available.

Treating Postpartum Hemorrhage: how does an Interventional Radiology Treatment Compare with Traditional Surgical Methods? all women who carry a pregnancy beyond 20 weeks’ gestation are at risk for postpartum hemorrhage, a dangerous complication of delivery that can cause a critical drop in blood pressure that may lead to shock and even death. in a large study, interventional radiologists determine the safety and effectiveness of pelvic arterial embolization?a minimally invasive treatment where bleeding is halted by using a catheter through the groin to inject small blood-stopping particles into the arteries supplying the uterus. (Embargoed for release until Tuesday, March 29, 2011, at 8 a.m. Eastern)

High Blood Pressure Decreasing Resistant Hypertension: Taking it to new Lows in a Minimally Invasive Way it is estimated that one in every four American adults has high blood pressure. High blood pressure increases the risk of heart and/or kidney disease and stroke because it makes the heart work too hard. does zapping certain nerves in the kidneys with energy offer an effective way at reducing and consistently controlling resistant high blood pressure?even when medications have failed? Are there other disease states that could adopt this treatment method? (Embargoed for release until Monday, March 28, 2011, at 8 a.m. Eastern)

To register for the Annual Scientific Meeting, visit SIRmeeting.org. Press registration is complimentary to credentialed media. for press registration only, contact Ellen Acconcia, (703) 460-5582, , or Maryann Verrillo, (703) 460-5572, .

SIR will hold two press conferences: from 11 a.m.-12:30 p.m. (Eastern) on March 28 and from 10-11:30 a.m. (Eastern) on March 29, featuring an overview of the latest research and discoveries in the world of interventional radiology.

For more information about the Society of Interventional Radiology and its 36th Annual Scientific Meeting, visit online at SIRweb.org or SIRmeeting.org.

About the Society of Interventional Radiology

Interventional radiologists are physicians who specialize in minimally invasive, targeted treatments. they offer the most in-depth knowledge of the least invasive treatments available coupled with diagnostic and clinical experience across all specialties. they use X-ray, MRI and other imaging to advance a catheter in the body, such as in an artery, to treat at the source of the disease internally. As the inventors of angioplasty and the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease, interventional radiologists pioneered minimally invasive modern medicine. Today, interventional oncology is a growing specialty area of interventional radiology. Interventional radiologists can deliver treatments for cancer directly to the tumor without significant side effects or damage to nearby normal tissue.

Many conditions that once required surgery can be treated less invasively by interventional radiologists. Interventional radiology treatments offer less risk, less pain and less recovery time compared to open surgery. Visit SIRweb.org.

The Society of Interventional Radiology is holding its 36th Annual Scientific Meeting March 26-31 at McCormick Place (West Building) in Chicago, Ill. The theme of the meeting is “IR Rising: Leading Image-guided Medicine,” chosen to reflect interventional radiology’s continued revolutionizing of modern medicine.

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WEDNESDAY, March 9 (HealthDay News) — the U.S. Food and Drug Administration on Wednesday gave lupus patients their first new treatment option in more than 50 years when it approved Benlysta as a way to ease the painful symptoms of this debilitating autoimmune disorder.

Injected directly into a vein, Benlysta is the first drug designed to target a protein that may reduce the number of abnormal B cells believed to be at the root of lupus, the FDA said in a news release. the last lupus drugs approved by the agency were Plaquenil (hydroxychloroquine) and corticosteroids; both were given the agency's blessing in 1955. back in 1948, aspirin was approved to treat the disease.

Lupus strikes women far more often than men, and symptoms typically first appear between the ages of 15 and 44. the joints, skin, kidneys, lungs, heart and brain can all be affected, and when symptoms flare up they include swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss and fatigue, the FDA said.

According to the agency, there are between 300,000 and 1.5 million lupus sufferers in the United States. Black women are three times more likely than white women to get the disorder.

"Benlysta, when used with existing therapies, may be an important new treatment approach for health-care professionals and patients looking to help manage symptoms associated with this disease," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

The approval was widely expected after an FDA advisory panel voted 13-2 in November to recommend approval of the drug, the Los Angeles Times reported, and Benlysta is expected to become a top seller for its maker, Human Genome Sciences inc., of Rockville, Md.

Benlysta's arrival has been much heralded because it comes on the heels of decades of disappointing efforts to craft new treatments for lupus, Sandra Raymond, president of Lupus Foundation of America, told the Times.

"It's an historic day. it really does open a door," Raymond told the newspaper. "Not that Benlysta is a miracle drug. It's not. I think the lupus community is sanguine about that. but they know that there are other companies coming behind" Human Genome.

More information

For more on lupus, go to the U.S. National Institutes of Health.