Orexigen resubmits obesity drug application in Europe

4 October 2013

Having experienced significant delays in gaining approval for its weight-loss drug, USA-based Orexigen Therapeutics (Nasdaq: OREX) has resubmitted the Marketing Authorization Application (MAA) for Contrave (naltrexone SR and bupropion SR) to the European Medicines Agency utilizing the EMA's Centralized Procedure.

Orexigen is hoping for approval of Contrave for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification. Assuming successful completion of the review process and potential approval in the second half of 2014, Orexigen would expect Contrave to be available to physicians and their patients in Europe in early 2015.

"Obesity is one of Europe's great health care challenges, with the prevalence of obesity tripling in many European countries in the past few decades," said Michael Narachi, chief executive of Orexigen, adding: "We believe, if approved, a medicine with Contrave's safety and efficacy profile, including safety information derived from the ongoing cardiovascular outcomes trial, can be an important part of the solution for the management of obesity in Europe."

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