VIVUS Inc. (VVUS), based on preliminary feedback from the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP, said it expects an opinion recommending against approval of the Marketing Authorization Application or MAA for Qsiva for obesity. The formal decision from the CHMP is anticipated following their October 2012 meeting. If a negative recommendation is issued in October, and depending on the nature of the objections, the company would either resubmit the MAA at a later date or appeal this decision and request a re-examination by the CHMP.
"We await the official decision and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe," said Peter Tam, president of VIVUS. The company said it would work closely with the CHMP to address the Committee's concerns.
Nearly 50% of adult Europeans are obese or overweight and there are limited treatment options in Europe to address this high unmet medical need. Qsiva was approved by the FDA in July 2012 and was recently introduced in the U.S. under the trade name Qsymia. Qsiva was studied in more than 3,500 patients over 56 weeks establishing it as a safe and effective treatment for obesity.
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