Acomplia granted French reimbursement

French drug major Sanofi-Aventis' anti-obesity agent Acomplia (rimonabant) is to be reimbursed by social security if a recommendation from the senior council of health is accepted by the Ministry of Health.

This comes as some relief for the company which has experienced a number of regulatory delays and setbacks in recent months for a product it views as genuinely innovative. Acomplia still remains off the USA market after over a year of deliberations by the Food and Drug Administration and, in Germany, the Health Ministry has decided not to reimburse the drug (Marketletter January 22).

However, even in France reimbursement will be limited to obese patients with diabetes in an initial phase, a population that numbers about 200,000. Sanofi company sources have said they want to avoid the drug being treated as something for "pill-poppers" who want to lose a few kilos. Clinical trials have shown that Acomplia also acts directly on factors creating cardiovascular risk in obese people. Meanwhile, the FDA is expected to publish its decision at the end of April and, if positive, this will open up two-thirds of the potential market for the drug, according to Paris-based drug industry analysts, with a much larger patient population and prices considerably higher than in Europe.