Orexigen files obesity drug Contrave for approval in Europe

5 10 2013

New Drug Approvals

Orexigen files obesity drug Contrave for approval in Europe

Orexigen Therapeutics  has submitted the Marketing Authorization Application (MAA) for Contrave, an investigational weight-loss drug to the European Medicines Agency (EMA). 

OREXIGNEThe La Jolla, CA-based  drug firm is using the EMA’s centralised procedure to seek approval for Contrave  Orexigen (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification. The company filed the application after meeting with the European agency to discuss the filing strategy and “both were supportive” of the company’s plan to file in advance of an eagerly-anticipated interim analysis of a cardiovascular outcomes trial called the Light study. Orexigen and the European regulator have also agreed upon an investigation plan in children and adolescents.

read all at

http://www.pharmatopics.com/2013/10/orexigen-files-obesity-drug-contrave-approval-europe/

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