May 4, 2009 / 3:29 PM / 10 years ago

CORRECTED - UPDATE 1-Sanofi expects FDA letter on heart drug in Q2

(Corrects byline with no changes to text)

* Says has not received FDA letter on Multaq

* Says FDA discussions on Multaq ongoing

(Adds details, background, share price)

By Noelle Mennella

PARIS, May 4 (Reuters) - France’s Sanofi-Aventis (SASY.PA) has not yet received a letter from the U.S. health regulator giving the go-ahead for the sale of heart drug Multaq, but expects a decision during the second quarter, it said on Monday.

The U.S. Food and Drug Administration had been expected to announce its ruling at the end of last month.

“The FDA did not issue a letter on April 30. We continue to work with them. We are approaching the final phase of the discussions and we should have a response during the second quarter,” a spokesman for the company told Reuters on Monday.

Shares in the world's fourth-largest drugmaker were down 1.76 percent at 43 euros by 1339 GMT, lagging a 1.11 rise in the French CAC 40 index .FCHI.

Sanofi has forecast annual sales of more than 1 billion euros ($1.32 billion) for Multaq, generically known as dronedarone.

It is aimed at delaying symptoms of atrial fibrillation — 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 — and reducing hospitalisations.

Morgan Stanley analysts have estimated sales could reach 3 billion euros, against consensus of about 1 billion, with Citi seeing sales of as much as 1.5 billion euros.

The FDA is expected to follow a recommendation by an independent panel in March that Multaq should be approved for delaying symptoms of atrial fibrillation, but that patients with severe types of heart failure should not be allowed to use the drug and that Sanofi may not claim the drug lowers the risk of death. [ID:nN16512529]

Researchers have said Multaq could be a safer alternative to amiodarone, a generic drug widely used to control irregular heartbeats although it is not approved for that condition and can cause damage to the lungs and the thyroid gland. ($1=.7554 Euro) (Writing by Sophie Taylor and Caroline Jacobs; Editing by Jon Loades-Carter)

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