Novartis’s Diabetes Drug Galvus Will Be Delayed

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. Novartis said on Monday the Food and Drug Administration would examine new data, which provide evidence that skin problems in a preclinical animal study have not been seen in clinical studies with patients treated for Type 2 diabetes.

"We have supplied additional data to the FDA in response to some questions over the last few weeks," James Shannon, Novartis’s head of pharmaceuticals development, said on a conference call.

"We remain very confident in the safety and efficacy of our product and in gaining U.S. approval," Shannon said. "We look forward to the first quarter of 2007."

The move leaves Novartis behind Merck’s new introduction of Januvia in the race for market share for the new class of diabetes drugs, known as DPP-4 inhibitors.

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