PARIS, Nov 16 (Reuters) - Sanofi’s irregular heart beat drug Multaq will no longer be reimbursed by the French health system from December, in a further setback to a medicine once seen as a blockbuster product.
The decision follows a July recommendation by France’s top medical authority, the Haute Autorite de Sante, that Multaq should be withdrawn from the list of drugs reimbursed by the state-run health system.
HAS said at the time Multaq, known chemically as dronedarone, was not sufficiently effective.
Reimbursement in France will stop from Dec. 1, 2011, according to a notice published in the government’s official bulletin.
A Sanofi spokesman said the company disagrees with the decision, saying that France is the only country in Europe to stop reimbursing Multaq.
Jean-Pierre Lehner, Sanofi’s chief medical officer, said the decision not to reimburse the drug is “not based on medical evidence and harms the appropriate patients who are currently treated with Multaq.”
Europe’s drug regulator restricted the use of Multaq in September, saying the drug should only be prescribed after alternative treatments have been considered.
Still, the agency said that for some patients with non-permanent atrial fibrillation, Multaq was a useful option, adding that for them benefits outweighed the risks of using the drug.
Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart beat in an uncoordinated manner. This can cause palpitations, shortness of breath and fatigue and raise the risk of more serious heart problems.
More and more people are suffering from the disease due to an aging population.
EU and U.S. regulators in July widened their review into whether Multaq could cause some forms of cardiovascular disease. That came on top of a probe into possible ties between Multaq and liver failure.
The broadened review was prompted by Sanofi’s decision to halt a late-stage clinical trial using Multaq in long-term sufferers, when it saw a “significant” rise in cardiovascular disorders such as heart attacks and strokes.
Before the latest problems, many analysts saw Multaq’s potential annual sales exceeding $1 billion.
Its sales totaled 172 million euros ($232 million) in 2010, including 128 million generated in the U.S.
Multaq received EU marketing approval in November 2009 for use in patients with non-permanent irregular heart beat. It was launched in France in October 2010. ($1 = 0.739 Euros)