Regulatory Update For Qnexa Could Signal A Change In The Obesity Landscape
This article was originally published in Pharmaceutical Approvals Monthly
New developments for Vivus’ weight loss drug Qnexa may mean that the regulatory environment for obesity treatments could be improving.
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Arena and Eisai expect to hear in the next week or so whether FDA will accept their answer to an October 2010 “complete response” letter and set a new action date for their novel weight loss drug.
Vivus’ weight loss drug Qnexa (phentermine/topiramate) will go before the Endocrinologic and Metabolic Drugs Advisory Committee again on Feb. 22 for an indication that excludes women of childbearing age. And despite additional safety data, cardiovascular concerns look to remain a major issue for the resubmitted application.
The biotech breathes new life into its obesity program now that it has reached agreement with FDA on a two-year cardiovascular safety study for Contrave.