The FDA has approved Sanofi-Aventis‘s Multaq (dronedarone) 400 mg tablets. Multaq, an anti-arrhythmic, is the first drug approved in the U.S. to show a clinical benefit to reduce cardiovascular hospitalization in patients with atrial fibrillation (AF) or atrial flutter (AFL), according to SA. The FDA’s approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.

“The FDA approval of Multaq is an important milestone in the management of atrial fibrillation or atrial flutter that demonstrates the commitment of Sanofi-Aventis to provide patients and physicians with important new medicines in therapeutic areas with significant healthcare needs,” said Christopher A. Viehbacher, chief executive officer of SA. “Sanofi-Aventis is proud of its ability to bring innovative therapies to market and contribute to reducing the public health burden of atrial fibrillation.”

To ensure the use of Multaq in the appropriate patient population, Sanofi-Aventis U.S. LLC has launched mPACT — Multaq Partnership for Appropriate Care and Treatment — the Risk Evaluation and Mitigation Strategy (REMS) developed by sanofi-aventis U.S. LLC. The mPACT Partnership was developed to assist healthcare professionals (HCPs) with the identification of appropriate patients and to ensure the safe use of Multaq while minimizing risk. The risk mitigation program consists of a Communication Plan for HCPs, a medication guide for patients and post-marketing surveillance.

“We are pleased that the FDA has granted approval of Multaq for patients in a therapeutic area that has seen few new treatment options in the last 20 years,” said Marc Cluzel, M.D., SA’s senior vice president, R&D.

The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 2.5 million people in the U.S. and 4.5 million people in the EU. Atrial fibrillation is a potentially life-threatening condition, with significant burden on patients, health care providers and payers.

Multaq® is under regulatory review by the European Medicines Agency (EMEA).