Orexigen's Mysimba Approved in Europe for the Treatment of Obesity

Orexigen Therapeutics has announced that the European Commission has granted marketing authorisation for Mysimba (naltrexone HCl/bupropion HCl prolonged release) as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension). This authorization applies to all 28 European Union (EU) member states.

"The granting of European marketing authorisation for Mysimba is a significant milestone for Orexigen.  European approval is an important step in our pursuit to bring new treatment options to the many patients who struggle with obesity in Europe and around the world," said Mike Narachi, CEO of Orexigen.

Obesity is one of the most significant public health challenges globally and being overweight or obese is a major risk factor for a number of chronic diseases, including diabetes and cardiovascular disease. In Europe, the prevalence of obesity has risen up to three-fold in the last two decades, and the World Health Organization estimates that over 20% of the adult European population is obese (BMI≥30 kg/m2). Adult obesity and overweight are responsible for up to 6% of health care expenditures in Europe; in addition, they impose indirect costs (due to the loss of lives, productivity and related income) that are at least two times higher.