Wednesday, September 17, 2014
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FDA schedules June meeting to re-examine Avandia clinical trial results

Two FDA advisory committees will have a joint meeting in June to reexamine a clinical trial done for GlaxoSmithKline's troubled type 2 diabetes drug Avandia.

FDA schedules June meeting to re-examine Avandia clinical trial results

The U.S. Food and Drug Administration posted a notice on the federal register that it will hold a joint meeting of two advisory committees on June 5-6 for discussion of results of a new and "independent" review of a previous clinical trial that GlaxoSmithKline did for its troubled type 2 diabetes drug Avandia. The original trials helped GSK gain approval for the drug.

As the Wall Street Journal noted on its web site earlier Friday, Avandia (rosiglitazone maleate) once had $3 billion in sales, but reports of side effects related to the heart caused sales to decline.

GSK paid penalties of $3 billion and pleaded guilty to three criminal charges in 2012. One of the criminal charges stemmed from allegations by federal prosecutors that GSK failed to relay safety data to the FDA from 2001 through 2007 about Avandia.

As discussed in a PhillyPharma post earlier Friday, the many lawsuits spinning from that period include a case being given Supreme Court review today.

A link to the FDA notice on the on the federal register is here.

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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