Vivus Inc. (VVUS) recently announced that women of childbearing potential can now use its obesity candidate Qnexa. The US Food and Drug Administration (FDA) has asked the company to remove the contraindication from the drug’s label, which so far indicated that the drug cannot be used for the treatment of women of childbearing potential. However, the contraindication for pregnant women remains.
Vivus resubmitted the new drug application (NDA) for Qnexa in October 2011, seeking approval for the use of the candidate 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 resubmission followed the company’s agreement with the FDA’s Endocrine and Metabolic Division in September 2011. The NDA resubmission included a proposed Risk Evaluation and Mitigation Strategy (REMS). Vivus is revising its proposed REMS based on the change in Qnexa’s label.
We note that the FDA accepted Vivus’ NDA for Qnexa in November last year. While, the US regulatory body has set a target date of April 17, 2012, for the application, the FDA’s advisory committee is expected to meet on February 22, 2012, to discuss the NDA.
Vivus also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Qnexa (for obesity) in December 2010. A response from the European regulatory body is expected in the first quarter of 2012.
The obesity treatments currently in the market include orlistat, sold by Roche Holdings Ltd. (RHHBY) as Xenical and by GlaxoSmithKline (GSK) as Alli.
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 believe that the removal of the aforementioned contraindication from Qnexa’s label will lead to incremental sales of the drug following approval.
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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