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Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation

Friday, August 8, 2008 General News
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BRIDGEWATER, N.J., Aug. 8 Sanofi-aventis(EURONEXT: SAN and NYSE: SNY) announced today that U.S. Food and DrugAdministration (FDA) has assigned priority review status for its New DrugApplication (NDA) for Multaq(R) (dronedarone). The priority review periodbegins on July 31, 2008.
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The priority review is granted to applications in which a new indicationor new drug product, if approved, has the potential to present a safe andeffective therapy where no satisfactory alternative exists compared tocurrently available therapies or marketed products.
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A registration dossier is also under regulatory review by the EuropeanMedicines Agency (EMEA) for a Marketing Authorization Application.

"We are pleased that the FDA has designated Multaq(R) for priorityreview," said Marc Cluzel, sanofi-aventis Senior Vice President, R&D forsanofi-aventis. "This follows the exciting results of the landmark ATHENAstudy that showed Multaq(R) significantly decreased the risk of cardiovascularhospitalizations or death from any cause in patients with AtrialFibrillation."

Atrial fibrillation is a major cause of hospitalization and mortality andaffects about 2.5 million people in the United States, as well as 4.5 millionpeople in the European Union and is emerging as a growing public healthconcern due to an aging population. Patients suffering from atrialfibrillation have twice the risk of death, an increased risk of stroke andcardiovascular complications, including congestive heart failure. Furthermoreatrial fibrillation considerably impairs patients' lives, mainly because oftheir inability to perform normal daily activities due to complaints ofpalpitations, chest pain, dyspnoea, fatigue or light-headedness.

About Multaq(R) (dronedarone)

Dronedarone (brand name Multaq(R)) is an investigational new treatment forpatients with atrial fibrillation, which has been discovered and developed bysanofi-aventis for the prevention and treatment of patients with atrialfibrillation or atrial flutter. Dronedarone is a multi-channel blocker thataffects calcium, potassium and sodium channels and has anti-adrenergicproperties. Dronedarone does not contain the iodine radical and did not showany 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 ofeveryone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York(NYSE: SNY).

Forward Looking Statements

This press release contains forward-looking statements as defined in thePrivate Securities Litigation Reform Act of 1995, as amended. Forward-lookingstatements are statements that are not historical facts. These statementsinclude product development, product potential projections and estimates andtheir underlying assumptions, statements regarding plans, objectives,intentions and expectations with respect to future events, operations,products and services, and statements regarding future performance.Forward-looking statements are generally identified by the words "expects,""anticipates," "believes," "intends," "estimates," "plans" and similarexpressions. Although sanofi-aventis' management believes that theexpectations reflected in such forward-looking statements are reasonable,investors are cautioned that forward-looking information and statements aresubject to various risks and uncertainties, many of which are difficult topredict and generally beyond the control of sanofi-aventis, that could causeactual results and developments to differ materially from those expressed in,or implied or projected by, the forward-looking information and statements.These risks and uncertainties include among other things, the uncertaintiesinherent in research and development, future clinical data and analysis,including post marketing,
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