Paris, France - It's the final nail in the coffin for rimonabant: Sanofi-Aventis announced today that it is halting all remaining clinical development programs for a drug that many people once hailed as a breakthrough therapy not only for obesity but for other cardiovascular risk factors. The news comes two weeks after the European Medicines Agency (EMEA) announced that it had asked the company to suspend marketing of the drug, on the grounds that its benefits no longer seemed to outweigh its risks.
At the time, Sanofi-Aventis said that the company remained committed to rimonabant, marketed as Acomplia, and that it was working to provide the EMEA with "additional evidence for the reevaluation of the benefit/risk profile of Acomplia in patients with diabetes and cardiovascular diseases through the ongoing clinical studies."
Those plans have been scrapped. In a brief statement announcing the company's discontinuation of all ongoing clinical studies, Sanofi-Aventis said that the decision "had been taken in light of recent demands by certain national health authorities. As a result, the feasibility of the global clinical development program has been compromised."
Dow Jones Newswires is reporting that France's drug regulatory body, the Agence Française de Sécurité Sanitaire des Produits de Santé, had noted five suicide deaths among patients participating in a rimonabant trial, as compared with just one suicide in the placebo arm of the same study . The French agency and others had asked Sanofi-Aventis to discontinue all trials, Newswires quotes a Sanofi-Aventis spokesperson.
The company plans to notify investigators of the decision today and is advising patients currently participating in a rimonabant trial to contact their doctors.
An FDA advisory committee recommended last year that the drug should not be marketed in the US, and one month ago, Merck announced it had halted development of its own cannabinoid-receptor blocker, taranabant, due to its overall safety and efficacy profile. But back when the first rimonabant trial results were presented in 2004, it was hard to find a single investigator or outside expert who had any misgivings about the drug or its possible side effects, certainly nothing that could have predicted the drug's swift demise. Those early results, suggesting that a single drug might tackle weight loss, smoking cessation, dyslipidemia, and metabolic syndrome, led more than one media outlet—heart wire and the Wall Street Journal among them—to describe the trial as sounding "too good to be true," a statement that has unfortunately proved prophetic.
Heartwire from Medscape © 2008
Cite this: Sanofi-Aventis scraps ongoing rimonabant research - Medscape - Nov 05, 2008.