FDA推迟肥胖药物Qnexa的决定日期

On April 9, the FDA announced that it had extended the decision date for Vivus’ obesity medication Qnexa by three months to July 17. The agency postponed its approval decision in order to make sure that it has enough time to review Vivus’ proposed Risk Evaluation and Mitigation Strategy (REMS). REMS is the scheme by which the company would provide education to patients, physicians, and pharmacists on the appropriate use of the drug and its associated risks; have measures in place to restrict the drug’s use only to approved sets of patients; and be able to closely monitor the drug’s safety. (As a reminder, the safety concerns with Qnexa are a potential increased risk of birth defects [especially cleft lip or cleft palate] and a slight increase in heart rate). While this extension delays an official approval/non-approval decision, we think the fact that the extension only concerns REMS – that is, how to mitigate risk after the drug is approved – seems to bode well for ultimate approval of Qnexa. We look forward to hearing the FDA’s decision by July 17 and hope that the agency exceeds expectations and finishes its review faster than anticipated.-VW.