
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).
The 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/
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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