VIVUS (VVUS) Says EMA CHMP May Recommend Against MAA for Qsiva
Tweet
Share
E-mailGet Alerts VVUS Hot Sheet
Join SI Premium – FREE
VIVUS, Inc. (Nasdaq: VVUS) announced that based on preliminary feedback from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), the company expects an opinion recommending against approval of the Marketing Authorization Application (MAA) for Qsiva (phentermine/topiramate ER) for the treatment of obesity. The formal written decision from the CHMP is expected following their October 2012 meeting. Depending upon the reasons presented in their formal communication, the company will either resubmit the MAA with additional data or appeal this decision and request a re-examination by the CHMP.
“Obesity remains an unmet medical need in the European Union (EU). We await the official decision, which should provide specifics on any additional requirements leading to the approval of Qsiva in the EU. We will work closely with the CHMP to address the Committee’s concerns. VIVUS is committed to making this important medication available to obese patients in the EU.”
Approximately 50% of adult Europeans are obese or overweight and there are limited treatment options in Europe to address this high unmet medical need. Qsiva, known by its US trade name as Qsymia™, was approved by the FDA in July 2012 and was recently launched in the United States. Qsymia was studied in over 3,500 patients over 56 weeks establishing it as a safe and effective treatment for obesity.
“Obesity remains an unmet medical need in the European Union (EU). We await the official decision, which should provide specifics on any additional requirements leading to the approval of Qsiva in the EU. We will work closely with the CHMP to address the Committee’s concerns. VIVUS is committed to making this important medication available to obese patients in the EU.”
Approximately 50% of adult Europeans are obese or overweight and there are limited treatment options in Europe to address this high unmet medical need. Qsiva, known by its US trade name as Qsymia™, was approved by the FDA in July 2012 and was recently launched in the United States. Qsymia was studied in over 3,500 patients over 56 weeks establishing it as a safe and effective treatment for obesity.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Edgewise Therapeutics Inc. (EWTX) Granted EU Orphan Drug Designations for Sevasemten
- Alto Neuroscience (ANRO) Reports Positive Phase 1 Results for ALTO-101
- Bunge Limited (BG) and Viterra Issue Statement on Canadian Competition Bureau Report
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
