EMA confirms negative view on Vivus' obesity drug Qsiva after appeal

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dealt a blow to US drugmaker Vivus (Nasdaq: VVUS) yesterday, when it confirmed its earlier decision to decline the Marketing Authorization Application for the company’s Qsiva (phentermine/topiramate ER) for the treatment of obesity in the European Union (The Pharma Letter October 19, 2012).

The reasons for the first decision were due to concerns over the potential cardiovascular and central nervous system effects associated with long-term use, teratogenic potential and use by patients for whom Qsiva is not indicated. Vivus requested a re-examination of the opinion. After considering the grounds for this request, the CHMP again declined the marketing authorization on February 21. In its consideration of the Qsiva MAA, the CHMP indicated that a pre-approval cardiovascular outcomes trial would be necessary to establish long-term safety.

"We are disappointed with the CHMP decision regarding Qsiva and the position the Committee adopted with respect to the need for a preapproval cardiovascular outcomes trial," said Peter Tam, president of Vivus, adding: "We have worked diligently throughout Europe with key opinion leaders and regulatory and risk management experts to highlight the favorable safety and efficacy profile of Qsiva. Despite the positive recommendation of the CHMP's own Scientific Advisory Group (SAG) and the high unmet medical need in obese patients, a majority of CHMP members have failed to recognize the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery."