CHMP urges against approval of Qsiva
Vivus has received the formal opinion from the EMA's CHMP following its 15th to 18th October meeting, which, as Vivus expected, recommended against approval of the MAA for Qsiva (phentermine+topiramate extended-release) for the treatment of obesity in the EU. The reasons for its decision were due to concerns over the potential cardiovascular and CNS effects associated with long-term use, teratogenic potential and use by patients for whom Qsiva is not indicated. Vivus intends to appeal this opinion and request a re-examination of the decision.
Qsiva is approved in the US, where is marketed under the tradename, Qsymia. It is intended as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30kg/m2 or greater (obese), or 27kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as hypertension, Type II diabetes or dyslipidaemia. The effect of the product on cardiovascular morbidity and mortality has not been established.