Novartis Provides Safety Update on Galvus

An updated analysis of pooled data involving more than 8,000 patients treated with Novartis’ Type 2 diabetes drug Galvus was finalized following European Union approval.

Novartis will discuss the data with the Committee for Medicinal Products for Human Use and seek a revision of prescribing information before Galvus is launched in European markets.

The analysis characterized a known imbalance in liver enzyme levels, which is more observable in the higher Galvus once-daily dosing regimen. The results showed 0.86 percent of Galvus patients taking the 100-mg once-daily dose, 0.34 percent of those taking the 50-mg twice-daily dose and 0.21 percent of those taking the 50-mg once-daily dose had elevations of the liver enzymes aspartate aminotransferase and alanine aminotransferase greater than three times the upper limit of normal, Novartis said.

At a 50-mg daily dosage, the incidence rate was comparable to the 0.20 percent in the pooled comparator group of about 4,400 patients taking metformin, a sulfonylurea or a placebo. The placebo rate was 0.40 percent, which was greater than the Galvus 50-mg twice-daily dose.