VIVUS, Inc. (NASDAQ: VVUS) today announced that the company has resubmitted the New Drug Application (NDA) for Qnexa® to the U.S. Food and Drug Administration (FDA). The resubmission follows an agreement reached in September 2011 with officials of the Endocrine and Metabolic Division of the Food and Drug Administration on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication 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 for Qnexa includes a contraindication for women of childbearing potential. The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
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.
Specific class of drugs can reverse diet-induced obesity, fatty liver and diabetes in mice