The FDA needs some time to think about Avandia safety--and apparently so do European regulators. This week the European Medicines Agency was expected to entertain recommendations on future use of the controversial GlaxoSmithKline diabetes drug. But the EMA Committee for Medicinal Products for Human Use (CHMP) said it needs to keep weighing the data.
Now, CHMP says it will wrap up its review of the Avandia evidence by September. "The committee noted that additional new data sets have become available very recently," EMA said in a statement. In the meantime, the agency is advising doctors to "strictly follow" Avandia's labeling.
At least some of that new data--if not all--would have been reviewed already by FDA's expert advisors for last week's high-profile meeting on the drug. That panel essentially voted to keep Avandia on the market, but with additional warnings and/or restrictions.
FDA itself is now deciding exactly what to do, and as was apparent during the committee meeting, agency staff is far from united in its approach to Avandia. The agency says it's going to deliver a verdict as soon as possible.
- see the release from EMA
- read the Reuters story
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