Novartis AG (NOVN) won a U.S. panel’s backing to sell a new medicine for a common lung disease at only one of two proposed doses, potentially delaying a combination drug that analysts estimate will top $1 billion in annual sales.
Outside advisers to the Food and Drug Administration voted 13-4 today in favor of Novartis’s 75-microgram dose of indacaterol as a once-daily treatment for chronic obstructive pulmonary disease. The panel voted 12-5 against a double- strength dose, saying there wasn’t proof that it worked better. The FDA isn’t required to follow these recommendations.
Novartis and Sosei Group of Tokyo are testing the higher dose in combination with another medicine for the lung disease. While the higher indacaterol dose is approved in Europe, a negative FDA ruling may delay the combination and cause Basel, Switzerland-based Novartis to lose ground against a competing drug being developed by GlaxoSmithKline Plc (GSK) and Theravance Inc. (THRX)
“I don’t believe as of yet it’s been proven that 150 is superior to 75,” panel member Daren Knoell, a professor of pharmacy and medicine at Ohio State University in Columbus, said today at the meeting at the FDA’s headquarters in Silver Spring, Maryland.
The new medicine, to be called Arcapta Neohaler, was turned down by the FDA in 2009 at doses of 150 and 300 micrograms. The agency raised questions at the time about the dose selection. Higher doses of similar medicines have been linked to death and worsening disease in asthma patients. The agency is scheduled to make a decision on the resubmitted drug application by April 1.
Novartis and Sosei’s combination of indacaterol and glycopyrronium bromide began in May the final of three stages of clinical testing generally required for regulatory approval. If approved, the combination may bring in annual sales of $1.5 billion in a “very conservative estimate,” according to Karl Heinz Koch, an analyst with Helvea SA in Geneva.
“Novartis has to meet a number of milestones for us to be able to raise our estimate,” he said in an e-mail last week. “One of these risks is the U.S. approval of” the single ingredient indacaterol.
More than 12 million people are diagnosed with chronic obstructive pulmonary disease and another 12 million probably have it and don’t know, according to the National Institutes of Health. The disease kills more than 120,000 Americans a year as blockages in the lungs lead to shortness of breath and disability. Some people refer to it as emphysema, chronic bronchitis or smoker’s cough.
Indacaterol is sold in Europe as the Onbrez Breezhaler and generated $33 million in sales in 2010 in its first full year of marketing. It is part of a group of medicines called long-acting beta adrenergic agonists, which are widely used in the U.S.
The FDA warned against long-term use of Glaxo’s Advair and AstraZeneca Plc (AZN)’s Symbicort last year and called for additional studies after reports of side effects with the long-acting drugs for asthma and chronic obstructive pulmonary disease. Both drugs have ingredients in the same family of medicines as indacterol.
Advair is London-based Glaxo’s biggest product with sales of 5.14 billion pounds ($7.94 billion) last year. Symbicort had sales of $2.75 billion for AstraZeneca, also of London.
Two studies released last month showed that combining Onbrez with Spiriva, a different type of treatment for chronic obstructive pulmonary disease, worked better than Spiriva alone. Closely held Boehringer Ingelheim GmbH of Ingelheim, Germany, hasn’t reported last year’s sales of the Spiriva inhaler, which the company sells with New York-based Pfizer Inc. (PFE) Sales in 2009 were 2.4 billion euros ($3.35 billion).
Forest Laboratories Inc. (FRX) of New York and closely held Nycomed A/S of Zurich announced FDA approval March 1 of their pill to reduce the risk of exacerbations in people with severe cases of chronic obstructive pulmonary disease. The drug, Daliresp, will be introduced in the second quarter.
To contact the reporter on this story: Catherine Larkin in Silver Spring, Maryland, at firstname.lastname@example.org