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Orexigen (OREX) Plans Resubmission of Contrave NDA by Year End 2013

August 27, 2013 7:32 AM EDT Send to a Friend
Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that the Light Study independent Data Monitoring Committee has recently confirmed that sufficient major adverse cardiovascular events (MACE) are expected to occur within the next two months, enabling the interim analysis to be conducted by early December and the potential resubmission of the Contrave® New Drug Application (NDA) by year end. The DMC also recommended that the Light Study continue as planned with no changes to the protocol.

"I'm proud of the progress made by our Light Study team," said Michael Narachi, Chief Executive Officer of Orexigen. "We remain focused on trial execution and launch preparation and look forward to the interim analysis and upcoming regulatory submissions."

Orexigen also today reiterated its plan to submit a Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.




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