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FDA memo backs Sanofi heart drug Multaq

http://www.reuters.com/article/rbssHealthcareNews/idUSN1651252920090316

WASHINGTON, March 16 (Reuters) - An experimental drug from Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) should be approved for delaying symptoms of atrial fibrillation and reducing hospitalization, a U.S. drug reviewer said in a memo released on Monday.

However, the company should not be allowed make claims that the drug, Multaq, decreases the risk of death, Food and Drug Administration reviewer Abraham Karkowsky said in the Feb. 17 memo prepared for an advisory panel that meets Wednesday.

The reviewer also said Multaq should not be used by patients with severe types of heart failure, known as Class III and IV.

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

Sanofi's CEO has called Multaq the company's most promising near-term asset. Some analysts forecast annual sales of the drug could top $2 billion if it wins approval.

In a separate summary prepared for the advisory panel, Sanofi said a large company-funded clinical trial showed Multaq reduced cardiovascular-related hospitalizations or deaths, a benefit not seen with other drugs used to treat atrial fibrillation.

Multaq "represents a new advance in the management of patients with atrial fibrillation/flutter, addressing an important unmet clinical need for patients and physicians," the company said. (Reporting by Lisa Richwine; editing by Gerald E. McCormick and Lisa Von Ahn)