Orexigen planning Contrave NDA resubmission by year end

Orexigen Therapeutics Inc. (NASDAQ:OREX) said it is on track to potentially resubmit an NDA for obesity product Contrave naltrexone/bupropion by year end. The company had previously said it expected to resubmit an NDA for Contrave this half. The news came after Orexigen said the IDMC for the Phase III Light Study evaluating the cardiovascular outcomes of Contrave expects a sufficient number of major cardiovascular events (MACE) -- at least 87 events -- for an interim analysis within the next two months and to conduct the analysis by early December. Orexigen also reiterated plans to submit an MAA for Contrave to EMA before the Light Study interim analysis.

In January, Orexigen said FDA proposed a procedure that would allow the DMC's summary report of the Light Study to form the basis of the NDA resubmission instead of the complete clinical study report for the interim analysis. FDA requested the cardiovascular outcomes in a 2011 complete response letter for Contrave, which is partnered with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) in North America. ...