BioCentury
ARTICLE | Regulation

Obesity double standard

FDA holding obesity drugs to higher cardiovascular standard than diabetes drugs

June 6, 2011 7:00 AM UTC

A recommendation by FDA that Orexigen Therapeutics Inc. demonstrate essentially zero cardiovascular risk for its obesity candidate Contrave naltrexone/bupropion signals that the agency is treating obesity very differently than diabetes, with the result that obesity drugs could have to meet a higher standard.

In a regulatory update for Contrave last Friday, Orexigen said it would suspend development of both of its obesity programs in the U.S. The reason, according to the company, is that the agency wants a cardiovascular outcomes trial that would demonstrate that the hazard ratio of major cardiovascular events associated with Contrave is "very near or below" one...