Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

VIVUS's Obesity Drug Rejected Again By European Medicines Agency

RELATED NEWS
Trade VVUS now with 

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.

Register
To receive FREE breaking news email alerts for VIVUS INC and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Colorado based doctor Dilip Joseph, who was kidnapped by the Taliban discusses his ordeal in detail in a book published by Amazon on Tuesday. Extending the rebound seen over the course of the previous session, stocks moved sharply higher during trading on Friday. The gains on the day partly offset the recent sell-off on Wall Street, although the major averages remain well off their mid-September highs. While the Ebola outbreak in the U.S. has thus far been limited to just three people, the results of a new CBS News poll suggest that news of the disease has contributed to a sharp drop in public confidence in the Centers for Disease Control and Prevention.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.