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UPDATE 1-Sanofi has not received any U.S. news yet on Multaq

Published 06/30/2009, 10:36 AM
Updated 06/30/2009, 10:40 AM
SASY
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* No FDA news yet on experimental heart drug Multaq

* Awaiting final marketing decision, no other comment

(Adds detail, background)

PARIS, June 30 (Reuters) - Sanofi-Aventis has not received any news yet from the U.S. health regulator on whether it will clear the French drugmaker's heart drug Multaq, touted as a blockbuster, for marketing.

If approved by the Food and Drug Administration, Multaq would be the first new key treatment in several years that Sanofi has pushed out of its pipeline.

The company needs new drugs to offset looming sales losses as several of its blockbusters go off patent.

"Sanofi-Aventis confirms that the FDA has not yet notified the company of their final decision regarding the Multiq new drug application," spokesman Jean-Marc Podvin said on Tuesday.

"We have been in ongoing discussions with the FDA regarding Multq and are awaiting a final decision."

He declined any further comment.

Sanofi has predicted annual sales of more than 1 billion euro ($1.41 billion) for Multaq, generically known as dronedarone, while some analysts see sales of as much as 3 billion euro.

Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart beat in an uncoordinated manner. which can cause palpitations, shortness of breath and fatigue and raise the risk of more serious heart problems.

An independent panel in March advised that patients with severe types of heart failure, known as Class III and IV, should not be allowed to use the drug and that Sanofi could not claim the drug lowered the risk of death.

Researchers have said Multaq could be a safer alternative to amiodarone, a generic drug widely used to control irregular heart beat although it is not approved for that condition and can cause damage to the lungs and the thyroid gland.

Sanofi shares were up 0.9 percent at 41.80 euros by 1428 GMT.

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