FDA panel to review Abbott’s Meridia Sept. 15

By Reuters
Posted Aug. 6, 2010 at 1:12 p.m.

Abbott Laboratories’ weight loss drug Meridia will be reviewed by an advisory panel to the U.S. Food and Drug Administration on Sept. 15, the company said Friday.

The meeting will take place a day before the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review lorcaserin, an experimental obesity drug being developed by Arena Pharmaceuticals Inc and Eisai Co. Ltd.

Abbott suspended European sales of Meridia, or sibutramine, in January after a recommendation by regulators that heart-related risks made the prescription drug too dangerous.

Abbott spokesman Scott Davies said Friday that Abbott reiterates its view of Meridia’s “positive risk/benefit profile” when used in the patient population for which the drug is approved.

Meridia’s global sales were about $300 million in 2009.

An FDA panel last month voted to recommend that a weight loss drug called Qnexa, being developed by Vivus Inc, not be approved by the agency due to concerns that it could cause depression, memory loss and potential birth defects if used among millions of overweight or obese Americans.

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