Sanofi withdraws Zimulti
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Roughly two weeks after a negative advisory committee review, Sanofi-Aventis withdraws its weight loss NDA for its cannabinoid-1 receptor antagonist Zimulti (rimonabant, formerly Acomplia). "We do not understand exactly some points in terms of the obesity indication and we want to have more time to discuss [those issues] with the FDA," Senior VP-Scientific and Medical Affairs Marc Cluzel said during a June 29 conference call discussing the decision to withdraw the application. Zimulti had a July 26 PDUFA date. A smoking cessation claim for rimonabant remains "not approvable" at FDA (1Pharmaceutical Approvals Monthly January 2007, p. 3)...