FDA denies immediate Contrave review but open to 'faster' path

Orexigen Therapeutics Inc. (NASDAQ:OREX) said FDA denied the company's request to immediately review and issue a decision on an NDA for Contrave instead of waiting for data from the agency-required cardiovascular study of the obesity product. However, Orexigen said that FDA is open to the possibility of a "faster path" to resubmission than the biotech had previously expected. Orexigen could resubmit the application before interim results, with the data submitted later during the review period. Orexigen did not provide a timeline for resubmission, citing procedural details that still need to be addressed. Orexigen also said on Monday that the Contrave CV trial -- the Phase III Light Study -- is expected to reach the required number of major cardiovascular events (MACE) two months sooner than expected; data could be available as early as 2Q13. FDA required the assessment of CV health outcomes in a 2011 complete response letter (see BioCentury, Aug. 12). ...