Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

VIVUS's Obesity Drug Rejected Again By European Medicines Agency

RELATED NEWS
Trade VVUS now with 
2/21/2013 7:32 PM ET

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

Editors Pick
The Reserve Bank of New Zealand on Thursday raised its Official Cash Rate by 25 basis points, to 3.00 percent from 2.75 percent. The decision was in line with expectations, and it marks the second straight month with a rate hike following 24 straight meetings in which the rate was not changed. New Zealand's economic expansion has considerable momentum, with GDP estimated to have grown by 3.5 percent in the year to March. Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter. Stocks moved mostly lower during trading on Wednesday, giving back some ground after trending higher over the past several sessions. Selling pressure was relatively subdued, however, limiting the downside for the markets. The major averages all closed in the red, although the tech-heavy Nasdaq underperformed its counterparts by a wide margin.
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.