(RTTNews) - French pharmaceutical company Sanofi-Aventis SA (SNY: News ) said Monday that its anti-Arrhythmic Drug - Multaq was granted marketing approval by the European Commission in all 27 European member states. The company plans the European launch of Multaq with the introduction in the United Kingdom and Germany in January 2010.

In July, Multaq has received FDA approval. Upon launching, Sanofi-Aventis booked net sales of EUR 13 million from Multaq, with over 19,000 prescriptions written by nearly 4,500 physicians, for the latest third-quarter. Multaq was authorized in Switzerland on September 25, and has been available in Canada since September 28.

In September, the CHMP, or Committee for Medicinal Products for Human Use of the European Medicine agency, or EMEA, issued a positive opinion recommending Multaq for clinically stable adult patients with a history of, or current non-permanent atrial fibrillation to prevent recurrence, or to lower ventricular rate.

Atrial fibrillation occurs when the heart's two small upper chambers or atria quiver instead of beating effectively. Blood isn't pumped completely out of them, so it may pool and clot. About 15% of strokes occur in people with atrial fibrillation and nearly 2.2 million Americans are diagnosed with atrial fibrillation. Currently available treatments reduce the frequency and duration of atrial fibrillation episodes. They are often given to prevent return of atrial fibrillation after cardioversion.

Sanofi-Aventis noted that Multaq is the first anti-arrhythmic drug approved in the European Union that has shown a clinical benefit to reduce cardiovascular hospitalizations or death from any cause in patients with AF/AFL.
Multaq approval is based on review of a comprehensive clinical data package including seven international, multi-center, randomized clinical trials involving more than 7000 patients with almost 4000 patients receiving dronedarone during the clinical development program. ATHENA, a trial involving 4628 patients in 30 months, reported a significant reduction cardiovascular hospitalizations and death by 24%.

Stefan Hohnloser, principal investigator of the ATHENA study said "This European approval is good news- Multaq is a significant step forward which could change the way we approach the management of atrial fibrillation and offers a new treatment option to physicians in a field where there has been no significant anti-arrhythmic drug innovation for almost 20 years."

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