Wednesday, June 13, 2007

FDA Panel Rejects Sanofi Weight Loss Drug Acomplia

I'm the first to admit I expected big sales once Acomplia was approved. However, it seems somewhat unlikely it will ever make an appearance in the United States. I've not heard any news about it's approval status in Canada, but I suspect this won't help.

From CNN:
A U.S. Food and Drug Administration panel Wednesday unanimously rejected Acomplia, a weight-loss drug from Sanofi-Aventis SA (SNY), on concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users.

The panel's decision is a blow to the Paris-based drug maker, which was hoping it could sell Acomplia on the U.S. market. The FDA typically follows its panels' advice but isn't required to do so. The FDA is set to make a final decision on whether to approve Acomplia, known generically as rimonabant, by the end of July.

"It was quite obvious there was serious concerns about the safety profile of rimonabant," said Eric Colman, the FDA's metabolic and endocrine drug product deputy director, noting that the 14 voting members said additional safety information should be required before the FDA should consider approving the drug.

If rimonabant were to be approved in the U.S., the drug would likely be called Zimulti because the FDA rejected the brand name of Acomplia. But approval is unlikely anytime soon. The FDA has been under fire from Congress about its handling of various drug-safety issues, including recent concerns that GlaxoSmithKline PLC's (GSK) diabetes drug Avandia raises heart-attack risks. ..more

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