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2007/3/27

U.S Health Panel to Review Sanofi's Acomplia in June

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@ 11:18 PM (18 months, 28 days ago)
Sanofi-Aventis said on Monday a U.S. panel of health experts would review its anti-obesity pill Acomplia in June, a move which analysts said caused new concerns over whether it would win U.S. marketing approval by the Food and Drug Administration.

Shares in the French drugmaker lost as much as 2 percent and were off 1.5 percent at 64.39 euros by 1454 GMT, while the DJ Stoxx European health sector index fell 0.5 percent.

"It (the panel meeting) indicates there are more question marks or concerns that need to be ironed out in a broader forum. It's a way for the FDA to hedge itself," Karl Heinz Koch, analyst at Vontobel said.

A Sanofi spokeswoman said that the Endocrinologic and Metabolic Drugs Advisory Committee meeting on June 13, to discuss the safety and efficacy of Acomplia, would not "endanger" the FDA's expected marketing decision on July 26.

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