Diabetes Drug Report -- News about Diabetes Drugs

Novartis expressed confidence on Nov. 28 that its DPP-4 inhibitor, Galvus, would be approved by the U.S. Food and Drug Administration in the first half of 2007, and said it also intends to seek regulatory approval for a combination of Galvus and older diabetes drug metformin.

The FDA on Nov. 13 put a three-month hold on action on Galvus to give it time to resolve concern whether problems encountered by animals taking the drug may pose risks to humans.

Novartis said it has presented the FDA with additional evidence that skin findings, including lesions, identified in monkeys during a preclinical animal study have not been seen in clinical studies involving some 1,000 patients treated for type-2 diabetes.

James Shannon, Novartis head of pharmaceutical development, told reporters in London that further clinical trial results supported the efficacy and safety of Galvus.

Galvus is one of a new class of drugs that enhance the body's ability to lower blood sugar. Merck & Co. last month received FDA approval for its DPP-IV drug, Januvia. Merck also has filed for FDA approval of a combination of Januvia with metformin.