Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA). Jack Lief, Arena’s President and Chief Executive Officer said, The meeting discussions reinforce our position that we have a path forward to seek FDA approval of lorcaserin . Based on guidance we have received from the agency, we are executing several activities and expect to resubmit the lorcaserin NDA by the end of 2011. As we continue discussions with the FDA to refine elements of our plan, we may identify ways to shorten this timeline. We will provide more details about our plan on the conference call and webcast this morning.
Arena submitted an NDA for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. In the CRL, the FDA outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues. The end-of-review meeting with the FDA included a discussion of the FDA’s position on issues identified in the CRL and Arena’s plan to respond.
