VIVUS, Inc.
VVUS announced today that the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) confirmed its October
18, 2012 decision to decline the Marketing Authorization Application (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.
"We are disappointed with the CHMP decision regarding Qsiva and the position
the Committee adopted with respect to the need for a preapproval
cardiovascular outcomes trial," said Peter Y. Tam, president of VIVUS. "We
have worked diligently throughout Europe with key opinion leaders and
regulatory and risk management experts to highlight the favorable safety and
efficacy profile of Qsiva. Despite the positive recommendation of CHMP's own
Scientific Advisory Group (SAG) and the high unmet medical need in obese
patients, a majority of CHMP members have failed to recognize the importance
of making this treatment option available, particularly for patients whose
only effective intervention is surgery."
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.
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