Novartis reports positive CHMP opinion for Galvus

Novartis has announced that it has made changes to the European prescribing information for Galvus (vildaglptin) which have prompted the issuing of a positive opinion for the compound as a treatment for type two diabetes from the Committee for Medicinal Products for Human Use (CHMP)

The compound was approved for this indication in the European Union in September 2007 as a combination treatment with metformin, thiazolidinedione or a sulphonylurea in a 50 mg once or twice daily or 100 mg once daily dose.

Following the pooling of new data showing fewer liver enzyme elevations in the 50 mg dose arms, the CHMP has recommended the approval of Galvus in a 50 mg dose together with a sulphonylurea and a twice-daily 50 mg dose together with a thiazolidinedione or metformin.

“The analysis of pooled data further characterized a known imbalance in liver enzyme levels, resulting in a recommendation not to prescribe Galvus to patients with liver impairment and to conduct liver monitoring at the start of treatment, every three months for the first year, and then periodically thereafter,” Novartis reports.

The company forecasts that that the compound will be made available to patients in the European Union during the first half of 2008.

Last month, Novartis reported presented new clinical data published in the Diabetes, Obesity and Metabolism journal showing the efficacy of Galvus as a treatment for type two diabetes.