logo
Share SHARE
FONT-SIZE Plus   Neg

VIVUS's Obesity Drug Rejected Again By European Medicines Agency

VIVUS Inc. (VVUS) 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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
An Illinois woman has filed a lawsuit against Starbucks accusing that the coffee retail giant is misleading customers by "underfilling" its cold beverages. According to the plaintiff, Starbucks is cheating customers by serving cold coffees with too much ice cubes and less coffee than advertised, "often... GNC Holdings Inc. (GNC) Monday said it has commenced a strategic review that could lead to potential sale of the company. Shares of GNC Holdings gained over 4 percent after the vitamins and health supplement retailer said it has hired Goldman Sachs and Wachtell, Lipton, Rosen & Katz to advise on... Workers at a giant construction company in Saudi Arabia have set fire to several company buses amid protests at being laid off and not being paid wages for several months. Employees at the Saudi Binladin Group set fire to company buses and staged demonstrations within the Mecca region in recent weeks after the company, one of Saudi Arabia's largest employers, laid off 50,000 foreign employees.
comments powered by Disqus
Follow RTT