Wednesday, June 13, 2007

FDA Panel Rejects A Bad Drug (Finally)

From the Wall Street Journal:

WASHINGTON -- A Food and Drug Administration panel Wednesday unanimously rejected Acomplia, a weight-loss drug from Sanofi-Aventis SA, due to concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users.

The panel's decision is a potential 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 the drug by the end of July.

Analysts believe the FDA will reject Acomplia, which is known generically as rimonabant, as the agency has been under fire from Congress about its handling of various drug-safety issues including recent concerns that GlaxoSmithKline PLC's diabetes drug Avandia raises heart-attack risks.


Earlier, Richard Gural, Sanofi's vice president of drug development and scientific affairs, had told the panel that Acomplia shouldn't be given to patients being treated for depression or a history of depression. He also said the company hasn't seen an increase in psychiatric problems associated with the drug in post-marketing reports.

The FDA has been concerned about psychiatric side effects such as depression. The agency also said there was a doubling of the rate of suicidal thoughts and behaviors seen in clinical studies of the drug. Last February, the FDA rejected Acomplia as a smoking-cessation product and said it needed more information on psychiatric side effects before it would consider approving the drug as a weight-loss treatment.

A Sanofi analysis of the data showed a lower "suicidality rate," finding a rate about 1.3 times higher than the rate seen in patients receiving a placebo, or fake drug. Company officials also said all of the incidences were associated with underlying depression and don't appear to be caused by rimonabant itself. Suicidality is an increase in suicidal thoughts and behaviors and doesn't refer to acts of suicide. The actual "suicidality" numbers are small, with 88 reports out of about 16,500 patients studied.


Rimonabant is designed to help block a chemical in the endocannabinoid system, a physiological system in the body that is believed to play a role in how the body regulates food intake. The FDA is concerned, however, that blocking the same chemical could increase the risk for other problems including mood disorders and neurodegenerative disorders like multiple sclerosis.

1 comment:

Grahame said...

It's great that the FDA did this, but I am a born skeptic and the fact that this was a French company makes me wonder if they would have been so certain about rejecting it if it had been a big American Pharmaceutical company.

Anyway, I don't want to detract from the fact that they finally got it right, so I'll just say "Well done FDA and about time!"