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FDA review supports Multaq

Sanofi-aventis' Multaq should be approved for delaying symptoms of atrial fibrillation but it should not be claimed that it reduces the risk of death

Sanofi-aventis' Multaq should be approved for delaying symptoms of atrial fibrillation and reducing hospitalisation but it should not be claimed that the treatment reduces the risk of death nor should it be given to patients with severe heart failure, according to documents posted on the FDA website yesterday.

In the memo prepared for the advisory panel who will meet to review the treatment on March 18, the FDA reviewers noted that "prevention of death from any cause was not established".

Data from a late-stage trial showed a combined reduction in the risk of hospitalisation and death for patients with atrial fibrillation using Multaq, compared to a placebo. But FDA reviewers Gail Moreschi and Valeria Freidlein, said the results were driven largely by a decrease in hospitalisations and not death.

Sanofi-aventis is seeking approval for Multaq to help restore and maintain normal heart rhythms in patients with atrial fibrillation – when the upper chambers of the heart beat in an uncoordinated manner. This condition can cause palpitations, shortness of breath and fatigue, and raise the risk for more serious heart problem.

The author of the memo, Abraham Karkowsky said that results from sanofi-aventis' clinical trials "are consistent with the conclusion that (Multaq) is a useful antiarrythmic to delay recurrence of symptoms associated with the underlying arrythmia and to prevent atrial fibrillation hospitalisations."

The French pharmaceutical company's CEO has called Multaq the company's most-promising near-term asset. Some analysts have forecast annual sales of $2 billion if it won approval and sanofi-aventis shares have already gained 4.1 per cent on the news.

A panel of outside experts will meet on March 18 to vote on whether the FDA should approve Multaq and whether restrictions should be placed on the approval. 

17th March 2009

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