Acomplia Diet Pill Pulled Back from FDA

The advisory channel to the FDA voted that the agency should not approve it due to the psychiatric risks observed from the use of Acomplia/Zimulti, the diet pill scientifically known as rimonabant from Sanofi-aventis.

Its company has withdrawn its application for U.S. approval because they lacked the time to fix the problems.

Marc Cluzel, a senior vice president of scientific and medical affairs at Sanofi, said on the conference call that the company is committed to getting the medicine approved in the U.S. Sanofi will meet with the regulator soon to try to better understand what’s needed to prove the drug’s safety, he said.

The medicine had an FDA action date of July 26 and the company decided to withdraw the application because there wasn’t time to respond to the concerns, Cluzel said.

“It is mainly due to our difficulty understanding some of the points raised by the advisory panel and written in the minutes of the advisory panel of the FDA, such as the duration of treatment requested for a chronic disease such as obesity,” he said.

The medicine is approved in 42 countries and is sold in 20 as a treatment for obesity and overweight patients with associated heart risk factors, the company said.

In the EU, Acomplia is already available but is not prescribed to those with history of depression, apparently because of the reported risks. But it’s been reported to lower blood sugar levels, it may be resubmitted as a diabetes treatment drug, specifically for Type 2 diabetes, than as an obesity pill.

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Tags: rimonabant, Zimulti, acomplia, diet pill, diabetes, Sanofi, FDA