Drugs: Bertrand will not oppose the delisting of Multaq

Written by Sandeep Nehra

The Health Minister Xavier Bertrand said on Monday he would not oppose the delisting of Multaq, cardiac arrhythmia drug against Sanofi, for which the Transparency Commission issued an opinion unfavorable to the maintenance of the management charge.

“I will not oppose the delisting, very clearly,” said Minister of France Inter.

“I decided to change the rules when advice will be taken by scientists, the Minister will be required to follow this advice, unless it wanted to oppose it with a reasoned opinion,” he added .

At its meeting on 22 June, the Commission on transparency of the Authority for Health (HAS) found that the medical service provided by the drug’s pharmaceutical group Sanofi “is insufficient to justify its continued support by the national solidarity. ”

“We regret that the opinion (of the Commission on transparency of the HAS) has been issued without waiting for the European medical reassessment” in the course of treatment, responded to AFP a spokesman of the group.

Marketed in France since October 25, 2010, the Multaq is currently undergoing a reassessment of the benefit / risk ratio by the European Medicines Agency, the results should be known in the second half of July.

This reassessment is especially following two cases of acute liver failure diagnosed in women taking Multaq.

“We believe that the Multaq is a useful drug for the treatment of patients with atrial fibrillation not permanent,” added the spokesman for Sanofi.

Xavier Bertrand also recalled that the French Agency for the Safety of Health Products (AFSSAPS) had in turn recommended that physicians be particularly vigilant in prescribing of Multaq, after stopping a clinical trial to extend the therapeutic indication.

“Decisions will be considered again in September on whether or not the Multaq,” said Mr. Bertrand.