FDA advisers recommend approving weight loss drug

Government advisers recommended approval Thursday of a weight-loss drug developed by Arena Pharmaceuticals, making it likely that a new obesity treatment will reach the market this year.

An advisory committee to the Food and Drug Administration voted 18-4, with one abstention, that the benefits of the drug, lorcaserin, outweighed the risks.

If the FDA approves the drug by its scheduled deadline of June 27, lorcaserin would be the first new prescription diet pill to reach the market in 13 years. The agency does not have to follow committee recommendations, although it usually does.

Another obesity medicine, Qnexa, developed by Vivus, was endorsed by the same committee in February. The FDA is to decide whether to approve it by July 17. Lorcaserin and Qnexa had received negative votes from the committee in 2010, and the FDA then did not approve them.

The positive votes this time stem in part from new data provided by the companies. But they also seem to reflect a growing feeling, voiced by several members of the advisory committee Thursday, that new tools are needed to treat a major health problem.

About one-third of adults are obese, and excess weight raises the risk of diabetes, heart disease and other illnesses.

Two main safety concerns led the FDA to turn down lorcaserin in 2010.

One was that the drug appeared to cause tumors in rats. Arena presented new data that seemed to convince some committee members the rat experience would not apply to people, especially at the doses to be used.

The other concern, which appeared more worrisome to the committee, was whether lorcaserin damages heart valves.

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New York Times