FDA Panel Backs Approval Of Takeda/Orexigen's Obesity Drug Contrave
This article was originally published in PharmAsia News
The promise of a randomized clinical trial to examine the cardiovascular risks of Orexigen's weight-loss drug Contrave - inlicensed by Takeda for North American commercialization and development rights - prompted a 13-7 vote in favor of approval by the agency's Endocrinologic and Metabolic Drugs Advisory Committee Dec. 7
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Timing of the study to be discussed at Dec. 7 advisory committee meeting.
Takeda, already a strong player in diabetes, is looking to be a leader in obesity as well. Obesity is a risky area of drug development, given regulatory concerns about safety and efficacy, not to mention payer resistance. But despite those roadblocks, Takeda added to its substantial obesity pipeline through a deal with Orexigen Therapeutics, announced Sept. 2
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