Sanofi-Aventis will not try again to sell diet drug rimonabant (Acomplia / Zimulti) in the United States for another three or four years, the company said on Sept. 17th, disappointing millions of dieters and leaving the door wide open for competitors.
Merck and Pfizer both have drugs that like rimonabant target the CB-1 receptor in late-stage trials, and a number of other companies are developing similar drugs as well.
While sales of rimonabant in the year it has been on the market in Europe have been disappointing, Sanofi made it clear it plans to forge ahead with studies of Acomplia in hopes of ultimately getting it approved in the U.S. both as a diet drug and treatment for type 2 diabetes.
"I'm confident in Acomplia because it is a unique product," Sanofi's head of research Marc Cluzel told reporters and analysts at a presentation on the company's research and development program.
While Acomplia was launched in Europe in 2006 and is also available in a handful of other countries, Sanofi withdrew its application in the United States after an FDA advisory panel unanimously recommended against approving the drug out of concern over side-effects including depression and suicidality.
Cluzel said Sanofi expects to refile its application with the FDA after longer-term data on the use of Acomplia has been gathered from the large CRESCENDO trial, which got underway in December 2005.
Sanof said it has enrolled approximately 11,000 of the 17,000 participants planned for this trial, and indicated it expects to have data from this study available to share with the FDA in 2010.
But while Sanofi's news on the near-term future of Acomplia as a diet drug may have been disappointing, the company indicated it now plans to press ahead aggressively with new studies aimed at winning approval of rimonabant as a main-line treatment of type 2 diabetes.
Sanofi said it plans in the first quarter of 2008 to launch a head-to-head trial comparing Acomplia to Merck's diabetes drug Januvia.
The company said it hopes to file for regulatory approvals worldwide for Acomplia as a treatment for diabetes in 2009, and follow that up by filing for a drug that is a combination of Acomplia and the older diabetes drug metformin in 2010.
Sanofi said it also hopes to file for regulatory approval of a drug that is a combination of Acomplia and a cholesterol-lowering statin in 2011.