Sanofi-Aventis (SNY) received good news earlier this week with the company receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Multaq. The CHMP recommended that Multaq should receive marketing authorization in the European Union. 

The CHMP has recommended the approval of Multaq for use in adult clinically stable patients with history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. The CHMP’s positive opinion is based on clinical data including results from seven international, multi-center, randomized clinical trials involving more than 7000 patients and including the landmark ATHENA trial. 

Phase III results on Multaq showed that it, along with standard therapy, significantly reduced the risk of cardiovascular hospitalizations or death from any cause by 24% compared to placebo. This data should help Multaq gain share. We expect the product to contribute significantly to revenues and believe it could eventually achieve blockbuster status. 

Multaq recently received approval from the U.S. Food and Drug Administration (FDA), Health Canada and Swissmedic (Swiss Health Authority). The U.S. approval process was not exactly smooth sailing with the company receiving a non-approvable letter from the FDA for its initial new drug application (NDA) filing in 2006. Sanofi resubmitted its NDA in 2008 and received a favorable response from an FDA advisory panel in March 2009 with final approval coming in July 2009. 

A response from the European Union regulatory authorities should be out shortly. Approval in the European Union would open up a huge market for the company. According to the company, AF affects about 4.5 million people in the European Union. It increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality. AF represents about one-third of hospitalization for arrhythmia in the European Union.
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