Novartis announces European approval for Galvus label update

Novartis has announced that Galvus (vildagliptin), its novel treatment for patients with type two diabetes, has received approval in Europe for its latest label update, a move which will pave the way for launches of the product throughout the EU.

The compound has been approved for use in combination with metformin, thiazolidinediones or sulfonylureas, the most common orally-administered antidiabetic compounds.

Novartis reports that the drug is well tolerated in a wide range of type two diabetes patients and effectively reduced blood sugar levels in these individuals.

According to the labelling update, Galvus can be prescribed in a 50mg once-daily dose in combination with a sulfonylurea, or in a twice-daily 50mg dose in combination with metformin or a thiazolidinedione.

James Shannon, chief medical officer at Novartis Pharma, said: “The approval of Galvus allows us to move forward with making this important new treatment option available to patients in Europe with type two diabetes.”

He added that the compound has been shown to offer additional efficiency when used in conjunction with currently-prescribed anti-diabetes drugs in a number of clinical trials.

In December 2007, Novartis announced that Galvus had moved closer to widespread availability in Europe, with EU health authorities giving the compound positive feedback.