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Regulatory Update For Qnexa Could Signal A Change In The Obesity Landscape

 
• By Lisa LaMotta

New developments for Vivus’ weight loss drug Qnexa may mean that the regulatory environment for obesity treatments could be improving.

The most recent update in the more than two year back and forth between FDA and Vivus Inc. over its obesity therapy Qnexa (phentermine/topiramate) may be a sign that the regulatory agency has shifted to a more positive mindset on weight-loss drugs.

Mountain View, Calif.-based Vivus announced Jan. 11 that FDA has asked the company to remove the contraindication for women of childbearing potential from its proposed label, though pregnant women will still be excluded. Vivus had proposed the contraindication as a way to mollify FDA’s concerns about birth defects associated with one of Qnexa’s components, the anti-epileptic topiramate Also see "Vivus Will Cut Population In Qnexa Resubmission" - Pink Sheet, 15 September, 2011.

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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