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FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atrial Flutter
Date:7/2/2009

ltaq(R) for patients in a therapeutic area that has seen few new treatment options in the last twenty years," said Marc Cluzel, MD, Senior Vice President, Research and Development, sanofi-aventis. "Sanofi-aventis' commitment to research and development in this area is rewarded today, and we hope it will benefit many patients suffering from this disease."

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 United States and 4.5 million people in the European Union. Atrial fibrillation is a potentially life-threatening condition, with significant burden on patients, health care providers and payers.

"It is exciting that Multaq(R) will now be available as a treatment option for patients with paroxysmal or persistent atrial fibrillation or atrial flutter," said Stuart Connolly, M.D., Professor of Medicine & Director, Division of Cardiology, McMaster University, Hamilton, Canada, and co-principal investigator in the ATHENA study. "Based on clinical studies, Multaq(R) reduces the risk of cardiovascular hospitalizations in patients with atrial fibrillation / atrial flutter, this outcome could change the way we approach the management of the disease."

Multaq(R) is to be given twice daily as a 400 mg tablet and should be taken as one tablet with the morning and evening meals. Treatment with Multaq(R) can be initiated in an outpatient setting. Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash.

A registration dossier of Multaq(R) is also under regulatory review by the European Medicines Agency (EMEA).

About dronedarone (Multaq(R))

Multaq(R), discovered and developed by sanofi-aventis, is one of the major therapeutic i
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