EMEA clears Galvus labeling update

Swiss drug major Novartis says that the European Medicines Agency (EMEA) has approved new labeling for Galvus (vildagliptin), its treatment for patients with type 2 diabetes. The drug, which first received EMEA approval last year (Marketletter October 8, 2007), had been the subject of further review following concerns about links to liver enzyme elevations (Marketletter November 12, 2007).

The new labeling, which is in line with revisions originally proposed by the Swiss firm, clears use of a 50mg-daily dose of Galvus in combination with a sulphonylurea, or 50mg of the drug twice-daily as part of a metformin or thiazolidinedione-based regimen. The EMEA also recommended that the product is not used by patients suffering liver impairment, and stipulated that diabetics who are treated undergo liver enzyme testing on a regular basis.

Novartis Pharma's chief medical officer, James Shannon, said that the firm welcomed the decision, adding that, in trials, Galvus had been shown to provide increased therapeutic efficacy when combined with any of the three leading treatments (Marketletters passim).