Swiss drugmaker Novartis AG (NVS) said Monday it is submitting further data to the U.S. Food and Drug Administration on the safety of its diabetes drug Galvus, meaning that the U.S. regulator's decision on approving the product will probably come at the end of February, three-months later than expected.
Novartis, based in Basel, said the additional data being submitted to the FDA provide further evidence, and confirm data submitted earlier, showing that skin findings identified in a single species during a preclinical animal study have not been seen in clinical studies with patients treated for type 2 diabetes.
The FDA late in 2005 had asked for such data for drugs belonging to a class of drugs to which Galvus belongs, so-called DPP4-inhibitors, Novartis spokesman John Gilardi said.
Galvus is one of Novartis' most important pipeline products, with expected annual sales of at least $1 billion.
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