Sanofi-Aventis Wants F.D.A. to Reconsider Heart Drug

Armed with new research data, Sanofi-Aventis, the French pharmaceutical giant, said Thursday that it planned to ask the Food and Drug Administration to reconsider the company’s experimental heart rhythm drug Multaq, which the regulatory agency rejected in 2006.

The company said it would resubmit its application for Multaq in the third quarter of this year based on results from a new study showing that the drug reduced both hospitalizations and deaths in patients suffering from atrial fibrillation.

Atrial fibrillation, in which the heart’s two upper chambers quiver instead of beating properly, affects an estimated 2.2 million Americans and an estimated 4.5 million people in the European Union. Patients with the disorder have increased risks of stroke and other cardiovascular complications, including heart failure.

Sanofi-Aventis released results of the clinical trial, called Athena, on Thursday at a meeting of the American Heart Rhythm Society in San Francisco.

The company’s shares rose 2.8 percent, to $38.58, in trading in New York.

The clinical trial, the company said, showed that Multaq decreased the risk of cardiovascular death by 30 percent when used in addition to standard therapy. The study also showed the drug reduced first cardiovascular hospitalization rates by 25 percent.