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12:00 AM
Jun 06, 2011
 |  BioCentury  |  Regulation

Obesity double standard

FDA holding obesity drugs to higher cardiovascular standard than diabetes drugs

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.

Orexigen estimates the resulting trial would have to enroll at least 60,000 patients.

The request is far more stringent than the criteria FDA applies to diabetes drugs. In that indication, the agency is willing to tolerate an increase of up to 30% in the risk of major cardiovascular events, and will even approve a drug that shows up to an 80% increase in risk in its premarket trials, with a requirement that postmarketing studies demonstrate an increase of 30% or less.

It is unclear whether FDA will hold all other obesity treatments to the same standard it has asked of Orexigen, and the agency was unable to comment for this story.

Contrave was the only one of three obesity candidates reviewed by FDA's Endocrinologic and Metabolic Drugs Advisory Committee to receive a positive vote last year (see BioCentury, Dec. 13, 2010).

But it also was the only one of the three candidates that showed a CV signal in its trials that could not be resolved with further data analysis. Contrave was associated with an increase in blood pressure and pulse in its Phase III studies.

On a conference call, President and CEO Michael Narachi...

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