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European Union declines approval of obesity drug Qsiva
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The European Medicines Agency’s Committee for Medicinal Products for Human Use has confirmed its October 18, 2012 decision to decline the Marketing Authorization Application for phentermine/topiramate extended-release tablets (Qsiva, Vivus), according to a press release. The drug is indicated for the treatment of obesity in the European Union.
Vivus requested a re-examination of the Committee for Medicinal Products for Human Use (CHMP) decision, but another decision not to approve the drug was made on February 21.
According to the press release, a pre-approval cardiovascular outcomes trial would be needed in order to determine the long-term safety of the drug.
The US version of phentermine/topiramate extended-release tablets (Qsymia, Vivus) were approved by the FDA in July 2012. The approval came with a warning for patients and clinicians under the Risk Evaluation and Mitigation Strategy (REMS), consisting of a medication guide designed to educate patients and clinicians about the important safety information to assure it is prescribed and taken properly. Moreover, the drug will only be dispensed through specially certified pharmacies, according to the FDA.
In addition to this safety measure, the manufacturer will conduct 10 postmarketing studies, including the long-term CV outcomes trial suggested by the advisory panel to investigate the effect of extended-release phentermine/topiramate on risk for major adverse CV events, such as MI and stroke.