Orexigen's Mysimba approved in the EU for obese and overweight patients with co-morbidities

US obesity speciality Orexigen (Nasdaq: OREX) has been granted marketing authorization by the European Commission for Mysimba (naltrexone HCl/bupropion HCl prolonged release) in obese and overweight patients.

The European Commission has approved Mysimba as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients who are classified by BMI as overweight or obese, in the presence of one or more weight-related co-morbidities such as type 2 diabetes or controlled hypertension. The drug was approved by the US Food and Drug Administration last year, and has been marketed with Takeda (TYO: 4502) in the USA as Contrave.

Mike Narachi, chief executive of Orexigen, said: "The granting of European marketing authorization 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.”