VIVUS Inc has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA (phentermine/topiramate) Controlled Release Capsules in the European Union (EU).

The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet. If approved in the EU, QNEXA could be recommended for obese adult patients (BMI = 30 kg/m2), or overweight patients (BMI = 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity).

"This centralized application for approval of QNEXA in the EU is an important step toward our goal of meeting a significant and currently unmet medical need in the EU, a market of strategic importance to VIVUS," said Leland Wilson, chief executive officer of VIVUS.