FDA advisory panel: asthma drugs should stay on market

Share this article:
An FDA advisory panel Wednesday voted unanimously in favor of continued marketing by GlaxoSmithKline and Novartis of three long-acting beta-agonist bronchodilators.
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.
Share this article:

Email Newsletters

More in News

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.

Gilead, Merck HCV marketing battle may be on horizon

Gilead, Merck HCV marketing battle may be on ...

Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.