Vivus Inc. (VVUS) recently announced the acceptance of the company’s new drug application (NDA) for Qnexa by the US Food and Drug Administration (FDA) for review. The regulatory body has set a target date of April 17, 2012 for the application. The FDA’s advisory committee is expected to meet in the first quarter of 2012, to discuss the NDA.
Vivus resubmitted the application on October 17, 2011, seeking approval for the use of Qnexa for the treatment of obesity, including weight loss and weight maintenance for obese patients (BMI > 30 kg/m2), or overweight patients (BMI > 27 kg/m2), with weight-related co-morbidities such as hypertension, type II diabetes, dyslipidemia, or central adiposity (abdominal obesity).
We note that the resubmission was in agreement with the FDA’s Endocrine and Metabolic Division reached in September 2011. The NDA resubmission included a proposed Risk Evaluation and Mitigation Strategy (REMS).
Vivus also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Qnexa (for obesity) in December 2010. A decision from the European regulatory body is expected in the fourth quarter of 2011.
The company is also evaluating Qnexa as a potential treatment for type II diabetes and obstructive sleep apnea.
Neutral on Vivus
We currently have a Neutral recommendation on Vivus. The stock carries a Zacks #3 Rank (Hold rating) in the short-run. We view the FDA acceptance of Qnexa NDA as a positive for the company, which currently does not have any marketed drug in its portfolio.
Apart from Qnexa, Vivus is seeking approval of avanafil for the treatment of erectile dysfunction (ED). The FDA has set a target date of April 29, 2012 for the drug. We expect investors’ focus to remain on avanafil and Qnexa’s approval.
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