Sanofi's Multaq Gains EU Approval - Analyst Blog

Sanofi-Aventis (SNY) received good news recently with the company gaining approval from the European Commission for its atrial fibrillation drug, Multaq. The product gained approval for use in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

The approval does not come as a surprise as Multaq recently received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The CHMP recommended that Multaq should receive marketing authorization in the European Union.

The EU approval is based on clinical data including results from seven international, multi-center, randomized clinical trials involving more than 7,000 patients and including the landmark ATHENA trial. Initial product launches are scheduled to take place in the United Kingdom and Germany in January 2010.

Multaq is already approved in the U.S., Canada, Switzerland and Brazil. The U.S. approval process was not exactly smooth sailing with the company receiving a non-approvable letter from the Food and Drug Administration (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.

Approval in the European Union should open up a huge market for Sanofi. According to the company, AF affects about 4.5 million people in the European Union. It increases the risk of stroke fivefold, 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.

Phase III results on Multaq showed that it, along with standard therapy, significantly reduced the risk of cardiovascular hospitalization or death 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.

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