Orexigen Therapeutics announced today that the Committee for Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a centralized marketing authorization for Mysimba (naltrexone HCI / bupropion HCI 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).

"The prevalence of obesity has more than tripled in many European countries in recent decades, and this rise in obesity has been accompanied with an increase in comorbid conditions including diabetes, cardiovascular complications, and fatty liver disease," said Nicholas Finer, BSc (Hons), MBBS, FRCP, Honorary Professor, National Centre for Cardiovascular Prevention and Outcomes, University College London Institute of Cardiovascular Science. "New treatment options are sorely needed in Europe where there is currently only one prescription drug available for weight management, a lipase inhibitor, which was approved in 1998. I am pleased the CHMP adopted a positive opinion for Mysimba after a careful assessment of its benefits and risks."

For more details, go to: http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=2001032