Sanofi-Aventis has been boosted by the news that France’s social security system has authorised the partial reimbursement of the company's anti-obesity drug Acomplia, two months after the German Ministry of Health confirmed that the product would not reimbursed at all there.
Acomplia (rimonabant) is now reimbursable in France for obese patients with type 2 diabetes uncontrolled by monotherapy with metformin or a sulphonylurea and whose HbA1c (blood sugar level) is in the range of 6.5%-10%. The French authorities noted that treatment with the drug should be an adjunct to diet and physical activity and will cost 71.63 euros for a 28-day course, 35% of which will be reimbursed. Sanofi added that there is no alternative medication to Acomplia on the list of reimbursable drugs.
The Franco-German firm had originally applied for wider permission for Acomplia to be reimbursed for obesity with associated health risks like cardiovascular disease as the firm has repeatedly pointed out that clinical trials have shown the drug improves ‘good’ cholesterol and fat levels in the blood.
The news from France is indeed positive as Sanofi regards Acomplia as a potential blockbuster but reimbursement is vital to achieving that status and the company plans to challenge the decision taken by the German authorities. Acomplia is also having a tough ride in the USA where the Food and Drug Administration has twice delayed its review of the treatment and no decision on approval is expected before the end of July.