Vivus Inc. (VVUS) recently announced the resubmission of the new drug application (NDA) for Qnexa to the US Food and Drug Administration (FDA). The company is seeking approval of Qnexa for an initial indication that includes the treatment of obese men and women of non-child bearing potential.
The company is 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 comes on the heels of Vivus’ September 2011 agreement with the FDA’s Endocrine and Metabolic Division. The NDA resubmission includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
The FDA plans to have an Advisory Committee meeting for the NDA in the first quarter of 2012, leading to a decision on the candidate in the second quarter of 2012.
Meanwhile, the company had 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.
We note that Vivus 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. We view the NDA resubmission of Qnexa 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 investor focus to remain on avanafil and Qnexa’s approval.
The stock carries a Zacks #2 Rank (Buy rating) in the short-run.
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