Sanofi-Aventis has received a boost from the French agency which deals with reimbursement after it gave a favourable recommendation for the use of the firm’s obesity and diabetes drug Acomplia.
The company reported that the Transparency Committee (Commission de la Transparence) has recommended that the government reimburse Acomplia (rimonabant) for obese patients who are unable to control their type-2 diabetes with a monotherapy of metformin or a sulfonylurea, and who have an HBA1c level of between 6.5% and 10%. The committee has also suggested that the treatment should be combined with diet and physical activity.
This is good news for Sanofi as the issue of reimbursement for Acomplia has dogged the firm since the treatment, which has the potential to be a blockbuster, was cleared in Europe last June. Indeed, the Franco-German drugmaker recently said that it intends to challenge in the courts the decision made by the German Ministry of Health which states that reimbursement is not appropriate because it is a ‘lifestyle’ drug.
Sanofi disagrees with this view and says Acomplia should be covered because it helps lower the risk of developing diabetes and cardiovascular disease, in addition to aiding weight loss. It has yet to be approved in the USA and the US Food and Drug Administration has only recently accepted its New Drug Application resubmission for Acomplia. A decision is due on April 26.
– Meantime, Sanofi also announced that it has been granted a priority review in the USA for a new indication of its low molecular weight heparin anticoagulant Lovenox (enoxaparin). The new indication would allow Lovenox to be used for patients suffering from non-ST segment elevation myocardial infarction and the firm noted has also applied for approval of this indication in Europe.
