Novartis Announces Two CHMP Positive Opinions For New Indications Of Galvus® And Eucreas® Combined With Other Diabetes Treatments

Date: Sep-26-2012Novartis has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions for new indications for the use of Galvus® (vildagliptin) and Eucreas® (vildagliptin and metformin) in combination with other treatments for type 2 diabetes patients1.

The first positive opinion was for vildagliptin in combination with insulin, with or without metformin, for patients with type 2 diabetes when diet, exercise and a stable dose of insulin do not result in glycemic control1. The second positive opinion was for vildagliptin in triple combination with metformin and a sulphonylurea for the treatment of type 2 diabetes when diet and exercise plus dual therapy with these two agents do not provide adequate glycemic control1.

"These CHMP positive opinions are important milestones in our efforts to offer physicians and patients effective and generally well-tolerated additional treatment options to help reach and maintain blood sugar goals," says David Morris, Primary Care Franchise Head of Development, Novartis Pharmaceuticals.

The CHMP positive opinion for the use of vildagliptin in combination with insulin was based on a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial (n=449) which demonstrated that vildagliptin 50 mg administered twice daily in combination with insulin, with or without metformin, reduced blood sugar levels (HbA1c) versus placebo (-0.7%; Phypoglycemia versus placebo2.

The CHMP positive opinion for the use of vildagliptin in combination with metformin and a sulphonylurea was based on a 24-week, randomized, double-blind, placebo-controlled, parallel-group trial (n=318)1. The study demonstrated that vildagliptin 50 mg twice-daily in combination with metformin and a sulphonylurea reduced blood sugar levels (HbA1c) versus placebo (-0.8%; Pobesity epidemic and an aging world population are contributing to the escalating incidence of type 2 diabetes and by 2030 it is projected that more than half a billion people will be diagnosed with the disease4. Type 2 diabetes accounts for 90 percent of all cases of the disease5.

About Galvus®

Galvus® (vildagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a class of oral diabetes medications that enhance the body's natural ability to control blood sugar. The Galvus® (vildagliptin) safety and efficacy profile has been established in a comprehensive clinical trial program that included more than 15,000 type 2 diabetes patients6.

Galvus® (vildagliptin) is approved in more than 100 countries across Europe, Asia Pacific, Africa and Latin America. It is indicated for the treatment of type 2 diabetes as a monotherapy and in combination with metformin, a sulphonylurea, a thiazolidinedione or insulin6. Specific indications vary by country.

About Eucreas/Galvus® Met

Eucreas®/Galvus® Met (vildagliptin and metformin) is a single-pill fixed-dose combination of Galvus® (vildagliptin) and metformin. Eucreas®/Galvus® Met (vildagliptin and metformin) is approved in more than 80 countries across Europe, Asia Pacific, Africa and Latin America for the treatment of patients with type 2 diabetes who are unable to control blood sugar with metformin alone7. Specific indications vary by country.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.