FDA action on new diabetes drug Galvus (vildagliptin) was delayed for at least a year after the agency asked Novartis to conduct an additional study to demonstrate the safety of the drug in patients with renal (kidney) impairment.

Galvus and Merck & Co.'s Januvia -- which was approved in late 2006 and already is on the market -- belong to a new class of drugs, so- called DPP-4 inhibitors, which increase and prolong the action of natural hormones in the body called incretins.

These decrease blood sugar by increasing consumption of sugar by the body, mainly through increasing insulin production in the pancreas, and by reducing production of sugar by the liver.

Novartis announced Feb. 27th that it had received an "approvable letter" from the the FDA for Galvus, but that the agency requested additional data, including the clinical study, before it will act.

The FDA delay is believed a result of agency concern that a biproduct of Galvus may build up in patients with kidney problems and lead to skin lesions, which were seen in tests with laboratory animals.

"We are confident in the safety and efficacy of Galvus and will continue working closely with the FDA to agree on what final actions are required to obtain US approval," said Dr. James Shannon, Novartis' Global Head of Development.