Galvus (vildagliptin) is a DPP-4 inhibitor that blocks the breakdown of incretin hormones in the body that stimulate the pancreas to produce insulin.
The approval is backed by the results from a 24-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled study, that evaluated the safety and tolerability of vildagliptin (50 mg qd) in patients with type 2 diabetes and moderate or severe renal impairment.
The data revealed that vildagliptin showed considerable improvements in glycemic control when added to existing anti-diabetic therapy
Novartis Primary Care Global Business Franchise head Timothy Maloney said the approval by the EC provides physicians with a new treatment to control blood sugar in a vulnerable patient population.
"Today’s approval underscores our commitment to making Galvus available to a broad range of at-risk patients with type 2 diabetes," Maloney added.