On November 7, 2007, Novartis AG announced that high doses of its diabetes drug, Galvus, could cause liver-safety problems. The announcement has delayed the drug’s path to approval and has raised questions about its future. The company said it would seek a revision to fix the problem before introducing it in Europe.

Patients taking 100 milligram doses of Galvus once-a-day were more prone to have liver-enzyme elevation when compared to patients taking 50 milligrams a day or 50 milligrams twice daily. Recommendations from the company will probably include changing doses to once- or twice-daily 50 milligram doses.

Galvus was approved by the European Union, but the new finding and announcement may delay its debut by several months as the label is finalized. Novartis intends to submit Galvus for approval in the U.S. in 2009, where separate skin toxicity warnings have set back its approval.

The drug is called a DPP-4 inhibitor, which is designed to enhance the body’s ability to lower elevated blood sugar, and may help control Type 2 diabetes. Drug makers also believe they could become blockbuster drugs because they are not associated with weight gain, a major side effect of some established drugs.

Source: “Novartis Diabetes Drug Delayed,” Reuters, November 7, 2007.