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Obesity drug

Vivus expects EU to reject Qsiva weight loss drug

Company awaits October 2012 decision

Vivus has revealed that it expects the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), to vote against approval of the Marketing Authorization Application (MAA) for Qsiva (phentermine/topiramate ER) for the treatment of obesity.

The announcement was made based on preliminary feedback from the European Medicines Agency.

Qsiva was approved by the FDA in July 2012 and was recently launched in the US under the trade name Qsymia.

The formal decision from the CHMP is expected following their October 2012 meeting. If a negative recommendation is issued, and depending upon the nature of the objections, the company will 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. "We will work closely with the CHMP to address the Committee's concerns.”

Vivus's Qsiva contains the appetite suppressant phentermine in combination with the anti-seizure drug topiramate. In 2008, Acomplia was launched in Europe but was withdrawn by its manufacturer Sanofi due to an increased risk of suicide.

Qsiva was the obesity second drug approved by the FDA in 2012. The FDA also approved Arena Pharmaceuticals’ drug Belviq in June, and Belviq is expected to go on sale in early 2013.

 

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