Sanofi-Aventis says that it intends to challenge in the courts the decision made by the German Ministry of Health which states that the firm’s anti-obesity drug Acomplia will not be reimbursed.
The Ministry of Health has upheld a recommendation from the German Federal Joint Committee, the G-BA, which said in October that it believes funding treatment with Acomplia (rimonabant) is inappropriate because it is a 'lifestyle' drug, a viewpoint which Sanofi disagrees with vigorously.
The French drugmaker has argued that Acomplia should be covered because it helps lower the risk of developing diabetes and cardiovascular disease, in addition to aiding weight loss. Indeed, Sanofi recently presented data from a Phase III trial of Acomplia which shows that treatment-naive patients with type 2 diabetes who received the drug experienced significant improvements in blood glucose control and weight loss, compared to those who took placebo.
The drug was cleared in Europe in June but since then, the issue of reimbursement for Acomplia has dogged Sanofi which has high hopes that the treatment will be a blockbuster. However sales will struggle to hit the heights if states in Europe refuse to cover Acomplia through their health insurance programmes.
Very few European countries (Sweden, Ireland and Denmark) have agreed to reimburse the drug and analysts believe that the announcement from Germany, the continent’s biggest market, could well influence the other major countries, France, the UK and Italy.
As for the USA, no decision on approval is likely there before the end of April as the Food and Drug Administration has only recently accepted its New Drug Application resubmission for Acomplia.