- The Washington Times - Tuesday, June 12, 2007


Regulators yesterday said Sanofi-Aventis‘ obesity treatment Acomplia may trigger suicidal behavior and other psychological side effects in some patients.

The Food and Drug Administration posted online its review of the drug — deemed effective for losing weight — ahead of a meeting tomorrow at which outside experts will vote on whether it should be approved. The agency does not have to follow the experts’ vote, though it often does.

The FDA is scheduled to issue its final decision on the drug July 27.

Based on clinical studies from the French drug maker, the FDA said patients taking Acomplia daily showed significant weight loss after two years.

However, agency staffers raised concerns about an increased rate of psychiatric adverse events among patients taking Acomplia, including depression, anxiety and insomnia. About 26 percent of patients on Acomplia reported such events, compared with 14 percent of patients on placebo.

The FDA also drew attention to a possible link between Acomplia and suicidal behavior. In studies of the weight-loss drug, Sanofi reported one patient committing suicide and eight having suicidal thoughts. Among patients taking a fake pill, Sanofi reported two suicide attempts and five instances of suicidal thoughts.

Regulators also noted a slightly higher rate of dizziness and headache among Acomplia patients, at 27.4 percent, compared with 24.4 percent patients on placebo.

Wall Street considers Acomplia a potential blockbuster despite hitting several regulatory snags since Sanofi submitted it for approval in 2005. The company originally touted Acomplia as both an anti-obesity pill and an anti-smoking treatment.

In February, however, the FDA rejected the company’s application for the anti-smoking use and said it needed more information on Acomplia’s psychiatric side effects before approving the drug to fight obesity.

The drug gained approval in the European Union soon after, but regulators there also did not approve the smoking use and limited approval to overweight patients who suffer additional health problems, including abnormal cholesterol and diabetes.

If approved in the U.S., Sanofi said it would market the drug under the name Zimulti, because FDA reviewers felt the name Acomplia could potentially mislead consumers.

Shares of Sanofi-Aventis fell 36 cents to $45.14 yesterday.

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