France Decides Sanofi’s Multaq Is ‘Insufficient’

France Decides Sanofi’s Multaq Is ‘Insufficient’

June 28th, 2011 // 12:54 pm @

Once again, Sanofi is facing trouble with Multaq. The latest difficulty comes from French regulators that have reevaluated the effectiveness of the drug, which is used to treat atrial fibrillation, after two patients developed severe liver damage. The move comes just nine months after Multaq, which

The High Authority for Health determined that Multaq is “insufficient,” which means French authorities could withdraw reimbursement, according to Liberation . French regulators appeared to have reluctantly approved the drug in the first place, but granted what was described as a high reimbursement rate amid speculation that Sanofi exerted political pressure as a large employer in the country.

Last fall, a new analysis of FDA adverse event reports indicate Multaq may cause or worsen heart failure, trigger potentially lethal irregular heartbeats and impair kidney function and questions have been raised about the study that was used by the drugmaker in its submission for FDA approval.

The backdrop to the decision by French regulators, however, can be traced to the Mediator scandal. The now-banned appetitte depressant was sold by Servier and linked to heart-valve damage. The French drugmaker denied allegations by government investigators that risks were deliberately concealed. The pill, which was prescribed to overweight diabetics, was withdrawn in November 2009, but more recently, French health authorities were accused of ignoring the warning signs .

French regulators now appear to be taking steps to look tougher on issues surrounding medicine. Recently, for instance, the Chantix smoking-cessation drug sold by Pfizer was removed the register of medicines for which patients can be reimbursed from government funds. However, given that Sanofi employs 26,000 people in France, the decision for Multaq will be, as Liberation write, a test of political will.

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