FDA issues a complete response letter for Sanofi-aventis' eplivanserin NDA

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the company's New Drug Application (NDA) for eplivanserin (Ciltyri(R)). Eplivanserin was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance.

Sanofi-aventis is currently reviewing the content of the complete response letter, in which the FDA has requested additional information regarding benefit-risk. The company will contact the FDA in the coming days to request a meeting to discuss what steps and data would be needed for approval.