Today the FDA announced that instead of reviewing Qnexa, the new weight loss drug by Vivus, combining Phentermine and Topiramate, they are pushing back the review date by 3 months to July 17th, 2012, to allow time to review all of the submitted data that Vivus provided the FDA.
“MOUNTAIN VIEW, Calif., April 9, 2012 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration (FDA) informed VIVUS (Nasdaq:VVUS) of an extended Prescription Drug User Fee Act (PDUFA) date for its review of the Qnexa New Drug Application (NDA) from April 17 to July 17, 2012. The three-month extension is a standard extension period.
On April 4, 2012, following the FDA’s request, VIVUS submitted the Qnexa Risk Evaluation and Mitigation Strategy (REMS), which was considered a major amendment to the NDA. The submission consisted of proposed REMS materials. Since the receipt date was within three months of the user fee goal date, the FDA is extending the PDUFA date by three months to provide time for a full review of the submission.
“The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February,” stated Leland F. Wilson, chief executive officer of VIVUS. “We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans.”
The Qnexa NDA seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI ≥ 30 kg/m2), or overweight patients (BMI ≥ 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes or dyslipidemia. Obesity is the second leading cause of preventable death and directly contributes to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke.”
