Diabetes drug Galvus (vildagliptin), the Novartis DPP-4 inhibitor that is seen as a direct competitor to Merck's Januvia (sitagliptin), was approved on Sept. 28 for use in the European Union, Norway and Iceland.

The approval by the European Commission is a major boost for the drug, which is being held off the U.S. market pending submission of additional safety data. Novartis has said it will not be ready to resubmit Galvus to the FDA until sometime in 2009.

The European approval allows Galvus to be used in combination with such other oral diabetes drugs as metformin, sulfonylureas, and thiazolidinediones.

Novartis had been anticipating approval of the drug in Europe since the EU's Committee for Medicinal Products for Human Use (CHMP) gave Galvus a positive opinion in July.

The committee last week also recommended approval of Eucreas, a combination of Galvus and metformin similar to Merck's Janumet, for sale in European countries.

"We are delighted that Galvus is approved in Europe for patients with Type II diabetes," said James Shannon, Novartis head of global development. "Our rigorous clinical trial programme has demonstrated the robust efficacy and tolerability of Galvus, which offers versatility to physicians looking for new treatment options."