Novartis Gets E.U. Approval For Diabetes Drug Galvus

European authorities have approved Novartis’s drug Galvus (vildagliptin), a DPP-4 inhibitor, as a new oral treatment for type 2 diabetes patients.

"The European Commission approved Galvus for use in combination with some of the most frequently prescribed oral anti-diabetes medicines — metformin, sulphonylureas, or thiazolidinediones," Novartis said.

The move had been expected. Novartis received a positive opinion from European health authorities in December on Galvus after it made changes to prescribing recommendations following liver safety concerns.

The company said two weeks ago that it would focus on launching Galvus in Europe as the U.S. Food and Drug Administration (FDA) had asked for a large new clinical trial. It had "stepped back" from developing Galvus in the United States, and have no plans to resubmit to the FDA.

"Galvus is not recommended for patients with liver impairment, and liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter," Novartis added.
Galvus is also not recommended for patients with moderate or severe renal impairment or congestive heart failure and should not be used in patients with type 1 diabetes.

This drug is in the same class as Januvia, which is a DPP-IV inhibitor, which works by preventing the breakdown of the GL:P-1 hormone. These drugs target the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes. Islet dysfunction, along with insulin resistance, is a contributory factor to type 2 diabetes, a progressive disease in which control of blood sugar deteriorates over time.

Novartis News Release