Orexigen's Mysimba approved in Europe for the treatment of obesity

EMA

Orexigen Therapeutics, Inc. today announced that the European Commission has granted marketing authorization for Mysimba (naltrexone hydrochloride / bupropion hydrochloride 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 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," said Mike Narachi, CEO of Orexigen.

For more details, go to: http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=2028990

Michael Wonder

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Michael Wonder

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