An advisory group is set to meet Monday to discuss the cardiovascularsafety of GlaxoSmithKline’s type 2 diabetes drug Avandia, and the drug may bein for a rough time.
The meetingwill pit GSK’s own analysis of Avandia (rosiglitazone) clinical trials againstan appraisal of several studies conducted by independent reviewers. The reviewers’report, released this week as part of a 436-page FDA briefing document, “largelyconfirms concerns first raised in May” by Dr Steven Nissen in The New England Journal of Medicine, accordingto The New York Times. Nissen’s meta-analysis found that patients taking Avandiaface a 43% higher risk of heart attacks than those taking other diabetes drugsor no medication, while the FDA report pegged the Avandia odds ratio at 38% for ischemic events.
Moreover,the new report said the risk of heart attack doubles when Avandia is added toinsulin. A similar risk was not found with patients taking Takeda’s Actos (pioglitazone).
GSK’s chief medical officer is set to make the case forAvandia’s safety. Across multiple sources of data, “there is no consistent orsystematic evidence that rosiglitazone increases the risk of myocardialinfarction or cardiovascular death” compared to other diabetes drugs, thecompany said in its own brief issued ahead of the meeting.
A review of both documents “make it seem unlikely Avandiawill remain unscathed,” said Forbes. Thepanel could suggest pulling Avandia off the market or recommend the FDA sit onits hands due to the conflicting studies. Perhaps more likely, the group couldrecommend placing additional warnings on the drug or that its use be restricted,particularly with those also taking insulin. In February the same group ofadvisors recommended Avandia’s label should get a “black box” warning about ischemicrisk.
Doctors have already voted with their prescription pads, sending GSK’s marketshare in the PPAR class of drugs down to 33% from 51% before Nissen’s report, according to IMS Health data cited by The Wall Street Journal. Actos now commands 67% of that market,compared to 49% in January. Last year Avandia had global sales of $3.38 billion—comprising7% of GSK’s total sales.
