Regulators in Europe have once more rejected Vivus' obesity drug Qsiva, insisting on a new heart safety study before approval can be considered.
Last October, the European Medicines Agency's Committee for Medicinal Products for Human Use declined to recommend approval of Qsiva (phentermine/topiramate extended-release) and Vivus requested a re-examination of the opinion. Now, after considering the grounds for this request, the CHMP has again declined the marketing authorisation.
The European regulator said that a pre-approval cardiovascular outcomes trial would be necessary to establish long-term safety, which has disappointed Vivus. Its president, Peter Tam, said that "we have worked diligently throughout Europe with key opinion leaders and regulatory and risk management experts to highlight the favourable safety and efficacy profile of Qsiva".
He added that despite the positive recommendation of the CHMP's own scientific advisory group "and the high unmet medical need in obese patients, a majority of CHMP members have failed to recognise the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery".
The drug was approved by the US Food and Drug Administration in July 2012 where it is sold as Qsymia. Vivus said its Phase III programme included over 4,500 subjects studied up to two years, "establishing Qsymia as a safe and effective treatment for obesity".