FDA advisory panel: asthma drugs should stay on market
The panel also ruled that a boxed warning should be added to Novartis' Foradil (formoterol) explaining that increases in asthma-related deaths have been seen in studies of the agent salmeterol, which is contained in GSK's Serevent and Advair. The two GSK drugs have carried the warning since 2003.
Although salmeterol and formoterol have not been directly compared, Foradil appears to work differently, Novartis said in FDA briefing materials. Nevertheless, "If FDA decides to adopt the recommendation of the committee, we will work closely with the agency to finalize the appropriate language," Novartis and Schering-Plough said in a joint statement. Foradil is marketed by Schering-Plough in the U.S.
The meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee came amid serious safety concerns raised by postmarketing studies of the drugs. A GSK trial known as SMART, announced in 2003, found 13 deaths among about 13,000 patients treated for 28 weeks with Serevent, compared with three deaths among about 13,000 placebo takers.
Severe asthma attacks also were reported in patients taking Foradil at doses above the FDA-approved dose. Another study done after approval was too small to draw conclusions from, the panel said.
The panel also looked at adverse event reports recorded in the FDA Adverse Events Reporting System database and reported among users of all three products, up to the last quarter of 2004.
Advair is a combination of Serevent and the agent fluticasone propionate. U.S. sales totaled $2.9 billion in 2004, according to IMS. Serevent registered U.S. sales of $273 million that year.
Foradil had U.S. sales of $82 million in 2004.