Galvus’ EU Launch Held Up by Safety Update to Physician Labeling

Novartis’ diabetes drug Galvus hit another roadblock as its launch in the European Union (EU) will be delayed until the firm receives approval for updated physician labeling.

Galvus (vildagliptin) was approved recently in Europe for the treatment of Type II diabetes. It is the second dipeptidyl peptidase-4 inhibitor approved in the EU, following Merck’s Januvia (sitagliptin).

Galvus’ U.S. approval is still pending at the FDA. The agency issued an approvable letter for Galvus earlier this year, requesting an additional study to assess the safety of the product in patients with impaired kidney function. During an investor conference, Novartis CEO Daniel Vasella said he does not expect the FDA to take action on the Galvus application until 2009.

The company is stalling the European Galvus launch until data that show subjects taking higher doses of the drug had a higher rate of elevate liver enzymes compared with those on lower doses are incorporated into the drug’s prescribing information. European labeling for the drug recommends patients undergo liver function tests before Galvus is prescribed.

In Europe, Galvus has a broader indication than Januvia, which is indicated only for use in combination with a thiazolidinedione or metformin, while Galvus holds indications for use in combination with thiazolidinediones, metformin or a sulfonylurea, such as glimepiride.