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Sanofi says FDA starts review of diabetes drug

Tue, 02/19/2013 - 11:45am
The Associated Press

French drugmaker Sanofi said Monday the Food and Drug Administration is starting a review of its once-a-day diabetes treatment lixisenatide.

Lixisenatide is a treatment for type 2 diabetes in adults. It works by increasing the body's insulin production and is part of a class of drugs called GLP-1 agonists. Other diabetes drugs in that group include Bristol-Myers Squibb Co.'s Byetta and Bydureon.

European Union regulators approved lixisenatide Feb. 1. Sanofi said it plans to start selling the drug late in the first quarter under the name Lyxumia. It has not chosen a U.S. brand name for lixisenatide.

U.S. shares of Sanofi rose $1.38, or 2.9 percent, to $49.40 in morning trading.

Sanofi's biggest-selling product is the diabetes drug Lantus. Sales of Lantus rose 23 percent to $6.55 billion in 2012, and Sanofi's total revenue from diabetes drugs grew 17 percent to $7.64 billion in 2012.

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