FDA decision over new obesity drug hangs in the balance

Jun 11 2007

The Food and Drug Administration (FDA) in the United States appears to be holding back on it's decision to grant approval for a weight loss drug.

The FDA says the drug Acomplia has adverse effects in some people in that it can prompt suicidal behavior and cause other psychological side effects.

The FDA's review of the drug comes before a panel of experts are about to vote on whether Sanofi-Aventis' obesity treatment should be given approval and although the federal agency is not obliged to follow the experts advice it more often than not does.

A definitive decision by the FDA is scheduled to be issued regarding Acomplia on July 27.

The FDA says clinical studies by the French drug maker indicated that patients taking Acomplia daily showed significant weight loss after two years.

However the FDA is concerned that 26 percent of patients in the trials taking Acomplia experienced adverse psychiatric events, including depression, anxiety and insomnia, compared with 14 percent of patients on a placebo.

The FDA also says there is 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 while among patients taking the placebo, Sanofi reported two suicide attempts and five instances of suicidal thoughts.

The FDA also says there was a slightly higher rate of dizziness and headache among Acomplia patients, at 27.4 percent, compared with 24.4 percent patients on placebo.

Acomplia is a potential blockbuster drug despite the hiccups in getting it approved.

It was originally presented in 2005 as an anti-obesity pill and an anti-smoking treatment but was rejected by the FDA for anti-smoking use until more information on it's psychiatric side effects were provided.

Known generically as rimonabant, the drug is already sold in 18 countries under the name Acomplia.

European Union regulators have approved Acomplia for overweight patients who suffer additional health problems, including abnormal cholesterol and diabetes, but not for smoking use.

If approved Sanofi plans to market the drug under the name Zimulti in the U.S.