VIVUS, Inc. (Nasdaq: VVUS) today announced that the company 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).
Obesity is a global epidemic, with approximately 150 million European adults affected, and the prevalence rising rapidly. It is estimated that 1 in 13 annual deaths in the EU is likely to be related to excess weight.
"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.
QNEXA® Achieves EMA 10% Weight Loss Benchmark Over Two Years
The mean weight loss for the mid- and full-dose of QNEXA® at the end of two years was 10.4% and 11.4%, respectively, which met the efficacy benchmark set by the EMA for obesity therapies. These results were shown to be sustained over a two-year period and were associated with significant improvements in weight-related co-morbidities such as hypertension, dyslipidemia and diabetes.
The EMA filing is comprised of data from over 4,500 overweight or obese patients with a broad range of weight-related co-morbidities. Two-year, double-blind data from SEQUEL (OB-305) were also included in the filing to demonstrate durability of treatment response and long-term safety.
The EMA's review of QNEXA® will follow their centralized marketing authorization procedure. If approved, QNEXA® could receive marketing authorization in all 27 EU member countries, potentially in late 2011.
SOURCE VIVUS, Inc.