BioCentury
ARTICLE | Clinical News

Contrave regulatory update

October 29, 2012 7:00 AM UTC

Orexigen 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 that the Contrave CV trial - the Phase III Light Study - is expected to reach the required number of major cardiovascular events (MACE) 2 months sooner than expected; data could be available as early as 2Q13. FDA required the assessment of CV health outcomes for Contrave under a 2011 complete response letter. Orexigen has an SPA from FDA for the trial (see BioCentury, Feb. 7, 2011 & Feb. 13, 2012).

In July, Orexigen asked FDA for the immediate review after the agency approved 2 obesity drugs without requiring preapproval CV outcomes data. The agency approved Qsyima phentermine/topiramate from Vivus Inc. (NASDAQ:VVUS, Mountain View, Calif.) in July, and Belviq lorcaserin from Arena Pharmaceuticals Inc. (NASDAQ:ARNA, San Diego, Calif.) and partner Eisai Co. Ltd. (Tokyo:4523; Osaka:4523, Tokyo, Japan) in June. Both drugs were approved with postmarketing requirements for CV outcomes trials. ...