ZURICH - A U.S. decision on approving Novartis AG's key diabetes drug Galvus has been delayed by three months after the firm asked the Food and Drug Administration to consider new clinical trials data, sending its shares sharply lower.
Galvus (vildagliptin) works by stimulating the cells (islet) in the pancreas to be more responsive to glucose, thus lowering blood glucose. Specifically, it is DPP4 inhibitor. DPP4 inhibitors prolong the half-life of incretins such as GLP-1 and GIP resulting in increased insulin secretion, decreased glucagon secretion, delayed gastric emptying, and reduced food intake. Several drugs of the DPP4 inhibitor class have been shown to improve blood glucose.
Novartis Pharmaceuticals division is trading down almost $1 to 58.44 just before market close.
Monday, November 13, 2006
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