Once-daily inhaled indacaterol was cleared as a maintenance therapy for chronic obstructive pulmonary disease, the Food and Drug Administration said today in a statement. The drug will carry the same boxed warning cautioning against use in asthma patients without a long-term asthma control medication, as is required for competing treatments, including GlaxoSmithKline Plc (GSK)’s Advair.
The new medicine will be marketed as the Arcapta Neohaler and will be available in a 75-microgram dose, said Morgan Liscinsky, an FDA spokeswoman. An agency advisory panel voted against a double-strength dose in March, saying there wasn’t proof it worked better. Higher doses of similar medicines have been tied to death and worsening disease in asthma patients.
“The approval of new long-term drugs for COPD that relieve breathing difficulty by opening airways provides another treatment option for the millions of people,” said Curtis Rosebraugh, director of the FDA’s Office of Drug Evaluation II, in the statement.
Basel, Switzerland-based Novartis’s application to sell the 150- and 300-microgram doses was turned down by the FDA in 2009.
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 may have annual sales of $303.5 million by 2014, according to the average estimate of six analysts surveyed by Bloomberg. Novartis and Sosei Group of Tokyo are testing the 150-microgram dose together with glycopyrronium bromide as a treatment for COPD that may have annual sales of $1.5 billion if approved, said Karl Heinz Koch, an analyst with Helvea SA in Geneva, earlier this year.
If the combination is delayed because of regulatory concern over the higher dose, it may give an edge to a competing product being developed by London-based Glaxo and Theravance Inc. (THRX), of South San Francisco, California.
Novartis’s American depositary receipts, each representing one ordinary share, rose 4 cents to $61.15 at 4:01 p.m. in New York Stock Exchange composite trading. Glaxo’s ADRs, each representing two shares, gained 10 cents to $43, and Theravance increased 42 cents, or 1.9 percent, to $22.63 on the Nasdaq Stock Market.
Indacaterol is sold in Europe as the Onbrez Breezhaler and generated $33 million in sales in 2010 in its first year of marketing. Competing treatments also include London-based AstraZeneca Plc (AZN)’s Symbicort; Spiriva, from New York-based Pfizer Inc. (PFE) and closely held Boehringer Ingelheim of Ingelheim, Germany; and Daliresp from New York-based Forest Laboratories Inc. (FRX) and closely held Nycomed A/S of Zurich.
Arcapta is the 20th novel medicine approved by the FDA this year following the approval earlier today of Johnson & Johnson and Bayer AG’s blood-thinner Xarelto. The agency may surpass the 2004 record of 36 new drug approvals, the most since at least 2001, according to FDA records. Twenty-one drugs were cleared last year.
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