Nov 4 2011
VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for Qnexa® to treat obesity. The company resubmitted the NDA on October 17, 2011.
The agency assigned a six-month, or class 2, review classification to the NDA, establishing April 17, 2012, as the Prescription Drug User Fee Act (PDUFA) target date. The FDA indicated that an advisory committee of the Division of Metabolism and Endocrinology Products (DMEP) will meet to discuss the Qnexa NDA in the first quarter of 2012.
The NDA resubmission 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, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling includes a contraindication for women of childbearing potential. The resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
The resubmission follows an agreement reached in September, 2011 with officials from the FDA DMEP on the filing strategy for Qnexa.
There are an estimated 80 million adult American men and women of non-childbearing potential, based on the NHANES 2008 study, who have a BMI > 30 (obese) or BMI > 27 (overweight) with at least one weight-related health risk, such as diabetes, hypertension or dyslipidemia and are at an increased risk of developing obesity-related cardiovascular and metabolic diseases.