CHMP Recommends Against Marketing Authorization Application for Vivus' Qsiva

VIVUS

announced Thursday that is has received the formal opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following their October 15-18 meeting. As expected, the CHMP recommended against approval of the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the European Union. The reasons for their decision were due to concerns over the potential cardiovascular and central nervous system effects associated with long-term use, teratogenic potential and use by patients for whom Qsiva is not indicated. The company currently intends to appeal this opinion and request a re-examination of the decision by the CHMP. "The lack of effective pharmacologic treatments for obesity remains a high medical need for many patients in Europe," stated Peter Tam, VIVUS' president. "We are committed to getting Qsiva approved in Europe and will work closely with the new rapporteur and co-rapporteur to make this happen."