Merck (MRK) today announced that the U.S. Food and Drug Administration has approved its respiratory drug Dulera for asthma patients 12 years of age and older. Dulera is a new two-in-one, fixed-dose combination, which was developed by Schering-Plough and then inherited by Merck when it acquired its smaller rival last year.
The new fixed-dose combines an inhaled corticosteroid with a long-acting beta2-agonist, which open airways and improve lung function. But recently the FDA raised concerns regarding LABA drugs, adding a black label warning to four widely used asthma drugs: GlazoSmithKline (GSK) Advair and Serevent, Novartis's (NVS) Foradil and AstraZeneca's (AZN) Symbicort. Dulera would carry a similar black label warning, which begins by simply stating that LABAs "increase the risk of asthma-related death."
Dulera is not indicated for the relief of acute bronchospasm, a condition common in asthmatics that causes the bronchi to narrow.
Merck adds that the approval of Dulera is based, in part, on Phase III studies that evaluated the safety and efficacy of the drug. Results from both clinical trials of Dulera showed patients receiving the drug in both available doses experienced significant improvement from baseline in lung function.
Merck's approval stands in contrast to Pfizer's (PFE) trial suspension from late Wednesday. The two Dow components were involved in large acquisitions last year and they both have to deal with looming patent cliffs. But while Pfizer seems to be running into hurdles on a regular basis, Merck's progress looks smoother. And while Pfizer's stock tumbled some 20% year-to-date, completely under-performing the market, Merck's declined about 2.5%, performing the same or better than major indexes.
Merck said Dulera is expected to be available nationwide by the end of July 2010. Merck shares advanced about half a percent right before the close of trading Thursday, a day the markets skidded about 1.5%.
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