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)...
You may also be interested in...
Sanofi-Aventis Expands Rimonabant Diabetes Program With Multiple Trials
Sanofi-Aventis is expanding its Zimulti (rimonabant) diabetes program after clinical study results showed the drug's effectiveness in reducing HbA1c is comparable to oral anti-diabetics
2007 NME Prospects Plentiful For Wyeth, Novartis – Other Firms Fall Short
The year 2007 holds the potential to fatten Wyeth's new drug lineup: after a lean 2006, when no Wyeth new molecular entities were approved, the company leads the industry in potential NME approvals for the coming year
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.