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.