Novartis receives EU approval for new Galvus specification

Novartis has been granted approval from the European Commission for its type 2 diabetes therapy Galvus to be used in a new specification.

Based on positive results from a clinical study, the drug has been ratified for use in the treatment of type 2 diabetes patients with moderate or severe renal impairment, a demographic for which therapy options are currently limited.

Data from a 24-week Novartis-sponsored study revealed that the drug is able to deliver significant glycaemic control improvements, as well as offering a safety profile comparable to placebo.

The drug is already available to those with no or mild renal impairment, with the new approval meaning that more patients are now able to benefit.

Timothy Maloney, global business franchise head for primary care at Novartis, said: "Today's approval underscores our commitment to making Galvus available to a broad range of at-risk patients with type 2 diabetes."

Last month, the company also received EU approval for Rasitrio, an innovative new high blood pressure therapy that combines three separate agents.