Sanofi-aventis announced that the FDA has assigned priority review status for its New Drug Application (NDA) for Multaq(R) (dronedarone). The priority review period began on July 31, 2008. The priority review is granted to applications in which a new indication or new drug product, if approved, has the potential to present a safe and effective therapy where no satisfactory alternative exists compared to currently available therapies or marketed products.A registration dossier is also under regulatory review by the European Medicines Agency (EMEA) for a Marketing Authorization Application. “We are pleased that the FDA has designated Multaq(R) for priority review,” said Marc Cluzel, sanofi-aventis Senior Vice President, R&D for sanofi-aventis. “This follows the exciting results of the landmark ATHENA study that showed Multaq(R) significantly decreased the risk of cardiovascular hospitalizations or death from any cause in patients with Atrial Fibrillation.” Atrial fibrillation is a major cause of hospitalization and mortality and affects about 2.5 million people in the United States, as well as 4.5 million people in the European Union and is emerging as a growing public health concern due to an aging population. Patients suffering from atrial fibrillation have twice the risk of death, an increased risk of stroke and cardiovascular complications, including congestive heart failure. Furthermore atrial fibrillation considerably impairs patients’ lives, mainly because of their inability to perform normal daily activities due to complaints of palpitations, chest pain, dyspnoea, fatigue or light-headedness.
