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Qsiva appeal

European agency confirms negative Qsiva decision

Regulatory body cites the need for a pre-approval cardiovascular outcomes trial

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has confirmed its October 2012 decision to decline the Marketing Authorization Application for Qsiva (phentermine/topiramate ER) for the treatment of obesity in the European Union.

Vivus, the developers of Qsiva, had requested a re-examination of the opinion. After considering the grounds for this request, CHMP again declined the marketing authorization on February 21, 2013. In considering the Qsiva application, 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 pre-approval cardiovascular outcomes trial," said Peter Y Tam, president of VIVUS.  "We have worked diligently throughout Europe with key opinion leaders and regulatory and risk management experts to highlight the favourable safety and efficacy profile of Qsiva. Despite the positive recommendation of CHMP's own Scientific Advisory Group and the high unmet medical need in obese patients, a majority of CHMP members have failed to recognise the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery."

Qsiva was approved by the FDA in July 2012 and is sold under the trade name Qsymia. It is approved in the US and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI over 30 or 27 with at least one weight-related medical condition.

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