22:13, Tuesday 8 March 2011
* Advisers urge approval of lower dose of indacaterol
* Higher dose key to combination product
* FDA usually follows panel recommendation
* Novartis shares close down 1.3 percent (Adds FDA, company comments; adds details on drug andcombination product)
SILVER SPRING, Md., March 8 (Reuters) – Novartis AG failed to win support from a U.S. advisorypanel for the highest proposed dose of a new lung drug, asetback that could delay development of a potential blockbustermedicine.
a Food and Drug Administration advisory panel voted 13-4 onTuesday to urge approval of a lower dose of inhaled drugindacaterol for treating chronic obstructive pulmonary disease(COPD), the third leading killer of Americans.
But in a 12-5 vote, the panel declined to endorse thehigher dose. Opponents said they were not convinced the higherdose provided any additional benefit.
“I saw no compelling evidence there was a significantdifference” between the two doses, said Dr. Peter Terry, thepanel chairman and a professor of medicine at Johns Hopkins inBaltimore.
The lower dose is 75 micrograms and the higher dose is 150micrograms.
The FDA usually follows panel recommendations. a finaldecision on indacaterol is due by April 1.
Modest sales are forecast for indacaterol as a stand-alonetreatment, but analysts say the drug could bring in more than$5 billion a year when combined with another lung therapy.
Novartis is seeking approval to sell indacaterol for COPD,also known as smoker’s cough because smoking is the majorcause. The disease causes breathing trouble and chroniccoughing and is sometimes fatal. An estimated 80 million peopleworldwide have moderate to severe COPD, according to the WorldHealth Organization.
Indacaterol is a once-a-day long-acting beta agonist, orLABA, a type of drug used to open to airways in patients withasthma or COPD. Other LABAs are taken twice a day. The drugscarry strong warnings about worsening of asthma and deaths insome patients.
Novartis and GlaxoSmithKline Plc are racingto sell a two-in-one medicine that combines a LABA withlong-acting muscarinic antagonist (LAMA) to produce a moreeffective, convenient therapy.
The Novartis combination product, known as QVA149, combinesa LAMA with 150 micrograms of indacaterol. An FDA rejection ordelay on that dose could stall the combination product,analysts said before the meeting.
Until recently, Novartis was not on the radar as a majorforce in lung drugs, which are difficult to make because of theinhaler devices they require for delivery.
now the field is emerging as pivotal to the company’sfuture through the drive into new branded drugs plus work withpartner Vectura on generic copies of products likeGlaxo’s Advair and AstraZeneca (LSE: AZN.L – news) ‘s Symbicort.
Indacaterol already is sold as a single therapy in Europe (Chicago Options: ^REURTRUSD – news)under the brand name Onbrez Breezhaler and had revenues of $33million in 2010. its U.S. name will be Arcapta Neohaler.
Novartis told the panel the higher dose provided betterrelief of COPD symptoms with no greater safety risk.
“Patients need a safe therapy that is optimal and not justminimally effective,” David Morris, head of respiratoryproducts for Novartis Pharma, told the panel.
Novartis shares fell 1.3 percent to close at $55.48 on theNew York Stock Exchange. (Reporting by Lisa Richwine; Editing by Tim Dobbyn)