An FDA advisory panel announced that Novartis AG’s Foradil asthma drug, marketed by Schering-Plough Corp., should have a warning about the risk for worsened breathing similar to that on GlaxoSmithKline Plc’s Advair and Serevent. The drug shares the ingredient salmeterol with London-based Glaxo’s Advair and Serevent. All three medicines work by easing constriction within the lung. The FDA panel also voted to say Serevent, Advair and Foradil are safe enough to remain on the U.S. market.
Advair and Serevent, which is the same drug combined with a corticosteroid, together outsell competing asthma treatments as well as Glaxo’s other products. The drugs’ sales last year totaled 2.5 billion pounds (about $4.4 billion). Foradil’s sales last year lagged at about $320 million. About 15 million Americans have asthma, which causes inflammation in the airways of the lung and constriction of nearby muscle.
The Serevent and Advair labels contain information based on results of a study that Glaxo began in 1996, Glaxo stopped the study early after 50 people taking Serevent died or had severe life-threatening breathing complications, compared with 36 people given a placebo. The FDA advisers also suggested the agency look at ways to more clearly explain those findings to consumers and doctors.
