Vivus Inc. (VVUS) will have to wait an additional three months before the US Food and Drug Administration (FDA) delivers a decision on the approvability status of its lead pipeline candidate, Qnexa. The FDA has extended Qnexa’s target date to July 17, 2012 from April 17, 2012.
The news was not completely unexpected as Vivus had submitted the Risk Evaluation and Mitigation Strategy (REMS) for Qnexa in the first week of April. The REMS is a major amendment to the NDA and consisted of proposed REMS materials. Since Vivus made the submission within three months of the target date, the FDA had to extend the PDUFA date in order to review the submission.
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 company is seeking to get Qnexa approved 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 would like to remind the investors that the FDA’s advisory committee voted 20-2 in February 2012, for the approval of Qnexa on the basis of a favorable benefit-risk profile of the candidate.
Vivus also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Qnexa in December 2010. The Committee for Medicinal Products for Human Use (CHMP) issued a 180-Day letter of intent (LOI) requesting additional information including risk minimization activities (the equivalent of REMS in the US) to address various issues relating to cardiovascular, neuropsychiatric and potential teratogenic effects of Qnexa. Moreover, the letter requires Vivus to discuss the benefit/risk profile of the different doses of Qnexa, the drug’s potential use in different patient populations, and the expected long-term benefit of treatment with Qnexa. The company plans to respond to the letter in the second 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.
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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