Regulatory Update For Qnexa Could Signal A Change In The Obesity Landscape
This article was originally published in The Pink Sheet Daily
Executive Summary
New developments for Vivus’ weight loss drug Qnexa may mean that the regulatory environment for obesity treatments could be improving.
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The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving the combination of phentermine and topiramate for weight loss during its second review of Vivus’ application.
FDA Says Qnexa Needs CV Outcome Trial, Asks Cmte. To Consider Pre- Or Post-Approval Timeframe
Endocrinologic and Metabolic Drugs Advisory Committee also will weigh in on a teratogenicity risk management strategy for Vivus’ weight-loss drug during a Feb. 22 meeting.
Advisory Committee Set To Review Cardiovascular Risk Assessment For Obesity Drugs
Recent guidance on Orexigen’s Contrave could provide clues about how the agency is leaning on drugs in the highly safety conscious obesity category. New analysis of SCOUT data for Abbott’s withdrawn Meridia (sibutramine) could crop up in the discussion, former panelist says.