Novartis Diabetes Drug Galvus (Vildagliptin) Approved in Europe

The potential blockbuster diabetes drug Galvus (DPP-4 Inhibitor) has been approved for use in the European Union. The approval by the European Commission had been expected after a July recommendation by a committee of experts at the European Medicines Agency. It will boost prospects for a drug that faces a lengthy delay in getting to market in the United States.

Novartis has said it would not be ready to resubmit Galvus to U.S. regulators until mid-2009, following a request for more safety data. The once-daily oral treatment was approved for use in combination with other common oral anti-diabetes medicines, metformin, sulfonylureas or thiazolidinediones, Novartis said in a statement. The approval applies to all 27 EU countries as well as Norway and Iceland.

Galvus works in a similar way to Merck & Co. Inc.’s Januvia but its path to the U.S. market has been delayed by worries over skin toxicity.

Merck’s big lead means Novartis may be at a disadvantage when its drug is finally approved in the United States, the world’s biggest drugs market, some analysts say.

Both Galvus and Januvia are so-called DPP-4 inhibitors, which are designed to enhance the body’s own ability to lower elevated blood sugar and could become an important new way to control type 2 diabetes, the most common form of the disease.

The manufacturers and many analysts believe DPP-4 drugs could become blockbusters because they are not associated with weight gain, a major side effect of some established diabetes drugs.