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Sanofi boosted by Multaq vote of approval

Published on 19/03/09 at 12:06pm

An FDA committee has recommended Sanofi-Aventis' new atrial fibrillation treatment Multaq, the company's most important late-stage drug.

The FDA cardiovascular and renal drugs advisory committee voted 10-3 in favour of the drug, which should secure it official marketing approval within a few months.

The company desperately needs major new products to secure its future income, which will be hit badly with the patent expiries of Plavix and Lovenox in the next few years.

"Sanofi-Aventis is pleased with the outcome of today's discussions and positive recommendation," said Jean-Pierre Lehner, the company's chief medical officer.

"The panel's insightful feedback which concluded with a positive vote, is an important step in gaining FDA approval of Multaq."

Multaq (dronedarone) is in the same class of drugs as existing treatment amiodarone, but has been developed especially to overcome the side effects seen in the older drug.

Some analysts forecast that Multaq could achieve peak annual sales in excess $2 billion, and the FDA committee's favourable review is major step towards achieving this goal.

The drug is backed by strong data. The ATHENA trial recently published in the New England Journal of Medicine compared dronedarone combined with standard therapy against standard therapy and placebo.

The trial showed a 29% decrease in the risk of cardiovascular death in patients with atrial fibrillation. Multaq also significantly decreased the risk of arrhythmic death by 45%, and overall there were 16% fewer deaths from any cause in the dronedarone group compared to placebo.

First cardiovascular hospitalisation was also reduced by 26% in the dronedarone group, suggesting the drug could represent a significant advance for these patients.

But not all the evidence generated in its development has been favourable. An earlier trial called ANDROMEDA was halted after it showed an increased incidence of death in patients taking dronedarone, which raised safety concerns for patients with congestive heart failure and moderate to severe left ventricular dysfunction.

Sanofi-Aventis has filed Multaq once before, but withdrew its application after negative decisions from the European and US regulators.

Europe's CHMP committee said it required further clinical trial data, namely a trial comparing it with an existing medication for atrial fibrillation. Sanofi recently published a trial comparing it with amiodarone, which it hopes will answer questions about its safety in particular.

Atrial fibrillation is the leading cause of hospitalisation for arrhythmia in the US and represents one third of hospitalisations for arrhythmia in Europe. Hospitalisation due to atrial fibrillation has increased dramatically (two-to-three fold) in recent years in the US.

The complex disease increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality.

There are approximately 2.5 million Americans and 4.5 million people in the EU with atrial fibrillation.

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