Sanofi-aventis announced that US Food and Drug Administration (FDA) has assigned priority review status for its New Drug Application (NDA) for Multaq (dronedarone). The priority review period begins on July 31, 2008.
The priority review is granted to applications in which a new indication or new drug product, if approved, has a 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.
Dronedarone (brand name Multaq) is an investigational new treatment for patients with atrial fibrillation, which has been discovered and developed by sanofi-aventis for the prevention and treatment of patients with atrial fibrillation or atrial flutter. Dronedarone is a multi-channel blocker that affects calcium, potassium and sodium channels and has anti-adrenergic properties. Dronedarone does not contain the iodine radical and did not show any evidence of thyroid or pulmonary toxicity in clinical trials.
"We are pleased that the FDA has designated Multaq for priority review" said Marc Cluzel, senior vice president, R&D for sanofi-aventis. "This follows the exciting results of the landmark Athena study that showed Multaq significantly decreased the combined risk of cardiovascular hospitalisations and death from any cause in patients with atrial fibrillation".
Atrial fibrillation is a major cause of hospitalisation 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.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone.