VIVUS Inc. (VVUS: Quote) announced that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP confirmed its October 18, 2012 decision to decline the Marketing Authorization Application or MAA for Qsiva (phentermine/topiramate ER) for the treatment of obesity in the European Union.
VIVUS 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 its consideration of the Qsiva MAA, CHMP indicated that a pre-approval cardiovascular outcomes trial would be necessary to establish long-term safety.
Qsiva was approved by the U.S. FDA in July 2012 and is sold under the trade name Qsymia. The pivotal Phase 3 clinical trial program included over 4,500 subjects studied up to two years, establishing Qsymia as a safe and effective treatment for obesity.
Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
by RTT Staff Writer
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