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Orexigen submits Contrave MAA

October 4, 2013 12:34 AM UTC

Orexigen Therapeutics Inc. (NASDAQ:OREX) submitted an MAA to EMA for Contrave naltrexone/bupropion to treat obesity. The company also reiterated plans to resubmit an NDA to FDA for the obesity candidate by year end after the interim analysis for the Phase III Light Study, which is evaluating the cardiovascular outcomes of Contrave. FDA requested the trial in a 2011 complete response letter for Contrave, which is partnered with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) in North America. In January, Orexigen said FDA proposed a procedure that would allow the summary report for the interim analysis to form the basis of the NDA resubmission instead of the complete clinical study report (see BioCentury Extra, Aug. 27). ...