Vivus Inc. (VVUS) recently received a major boost when the US Food and Drug Administration’s (FDA) advisory committee recommended the approval 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).
The committee voted 20-2 in favor of the approval on the basis of a favorable benefit-risk profile of the candidate.
We note that Vivus resubmitted the new drug application (NDA) for Qnexa in October 2011. The resubmission followed the company’s agreement with the FDA’s Endocrine and Metabolic Division in September 2011. The FDA accepted the NDA in November last year and set a target date of April 17, 2012, for the application.
Vivus also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Qnexa (obesity) in December 2010. A response from the European regulatory body is expected in the first quarter of 2012.
Obesity treatments currently in the market include orlistat, sold by Roche Holdings Ltd. (RHHBY) as Xenical and by GlaxoSmithKline (GSK) as Alli.
Recently, in January 2012, Vivus announced that the FDA suggested a change in the proposed label for Qnexa. Earlier, the proposed label mentioned that the drug would be contraindicated for women of childbearing potential and pregnant women. The FDA asked the company to remove the contraindication for women of childbearing potential from the drug’s proposed label. However, the contraindication for pregnant women remains.
We believe that the removal of the aforementioned contraindication from Qnexa’s proposed label will lead to incremental sales of the drug following its approval.
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 expect investors’ focus to remain on Qnexa and avanafil’s approval. 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.
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