Avandia in the hot seat in EU, US

As the FDA preps for next week's advisory panel review of Avandia, European regulators have launched their own safety probe of the drug. Prompted by new studies released in June linking the GlaxoSmithKline (NYSE: GSK) diabetes med to increased risk of stroke and cardiovascular problems, the European Medicines Agency will sift through the evidence at a committee meeting starting July 19. The group will recommend whether to pull Avandia off the market, suspend sales temporarily or change its approval.

"The EU reviewing the dossier is somewhat of a surprise," Royal Bank of Scotland analyst Michael Leacock told Bloomberg. It's the second time this year the agency has looked at Avandia safety.

GSK officials continue to point to the clinical trials of the drug for support: "Since 2007, we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia," VP Murray Stewart tells the Philadelphia Inquirer, "and together they show that this medicine does not increase the overall risk of heart attack, stroke or death."

Meanwhile, a lengthy FDA staff review of the drug has been posted in preparation for Tuesday's advisory panel meeting--and the news isn't good. The reviewers see "problems with the handling of RECORD cases." They single out four cases that "represent what we judge to be the worst mishandling of events in RECORD, mishandlings that we judge should not be found even as single occurrences and that suggest serious flaws with trial conduct," according to the document.

Avandia's critics have long asserted that the RECORD study was both weakly designed and too short to prove anything, the New York Times notes. Furthermore, the Senate Finance Committee investigation found GSK may have improperly influenced the independent experts in charge of the study. And now, the review finds the study's underlying data were misinterpreted. Instead of little risk to the heart, the RECORD study actually hints at substantial risks, the NYT points out.

In its own briefing document, GSK says its data shows the drug to be safe for diabetes patients: "Taken together, the totality of the data from [integrated clinical trials], observational, and large controlled clinical studies continue to support the overall positive benefit risk profile of [Avandia] as an important medicine for type 2 diabetes mellitus (T2DM) patients."

Analysts and diabetes drug makers are watching events closely, and so are doctors seeking guidance. "I think it is going to be put in the hands of the advisory committee, and I think that it is going to be a coin toss," Sanford C. Bernstein analyst Tim Anderson tells the Inquirer.

- check out the EMA release
- get GSK's statement
- read the NYT article
- read the Inquirer piece
- get the news from Bloomberg
- see the Reuters story
- find an article from CNN

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