ARTICLE | Regulation

It Pays to Weight

FDA panel backing for Orexigen: a boost for Qnexa, but not lorcaserin?

December 13, 2010 8:00 AM UTC

Sometimes going last can be a good thing. After two other obesity candidates failed to win the support of FDA advisory committees and Meridia sibutramine was taken off the market in October, Orexigen Therapeutics Inc. had a pretty good roadmap for what it had to do to win the panel's endorsement. The company thus came prepared to convince the panel that Contrave fixed-dose naltrexone/bupropion should be approved despite cardiovascular safety concerns.

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that the benefit-risk profile of Contrave supported approval as a long-term treatment for obesity. The panel also voted 11-8 that a cardiovascular outcomes trial to assess Contrave's risks could be conducted post-approval rather than pre-approval...