BRIDGEWATER, N.J., Aug. 8 /PRNewswire-FirstCall/ -- Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) announced today that U.S. Food and Drug
Administration (FDA) has assigned priority review status for its New Drug
Application (NDA) for Multaq(R) (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 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.
About Multaq(R) (dronedarone)
Dronedarone (brand name Multaq(R)) 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.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone.
