Novartis drug Galvus® approved in EU

Novartis announced today that the European Commission has approved Galvus® (vildagliptin) (50 mg once a day) for the treatment of type 2 diabetes patients with moderate or severe renal impairment1. Galvus is currently available for patients with no or mild renal impairment and this approval expands treatment options for patients with moderate or severe renal impairment1.

Renal impairment affects approximately one quarter2 of the 366 million people worldwide with diabetes4 and is a major cause of death in this population5. Controlling blood sugar levels in patients with type 2 diabetes and renal impairment can be complex as many oral anti-diabetic medicines are not recommended for use, are contraindicated or should be used with caution3. As a result, physicians have few treatment options3 for these high-risk patients5.

“This approval provides physicians with a much-needed new treatment to control blood sugar in a vulnerable patient population whose management is highly challenging,” said Timothy Maloney, Global Business Franchise Head, Primary Care, Novartis. “Today’s approval underscores our commitment to making Galvus available to a broad range of at-risk patients with type 2 diabetes.”

The approval is based on the results of the largest study to date of a DPP-4 inhibitor in patients with renal impairment6. The Novartis-sponsored, 24-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled study (n=515) assessed the safety and tolerability of vildagliptin (50 mg qd) in patients with type 2 diabetes and moderate or severe renal impairment6. The trial showed that vildagliptin had a similar safety profile to placebo in these patients6 and resulted in significant improvements in glycemic control when added to existing anti-diabetic therapy6.

“The combination of good tolerability and effective blood sugar control is critical in this population but ultimately patient safety is of paramount concern,” said Professor Per-Henrik Groop, Helsinki University Central Hospital, Helsinki, Finland. “The data supporting this approval demonstrate that with vildagliptin good tolerability can be achieved without compromising on efficacy.”

About Galvus

Galvus (vildagliptin) is a DPP-4 inhibitor that works by blocking the breakdown of ‘incretin’ hormones in the body that stimulate the pancreas to produce insulin1. Its mechanism of action targets the dysfunction in the pancreatic islet alpha and beta cells that cause high blood sugar levels in patients with type 2 diabetes1.

In the European Union, vildagliptin is indicated for the treatment of type 2 diabetes as dual oral therapy in combination with:

• Metformin, in patients with insufficient glycemic control despite maximal tolerated dose of monotherapy with metformin1.
• A sulphonylurea, in patients with insufficient glycemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance1.
• A thiazolidinedione, in patients with insufficient glycemic control and for whom the use of a thiazolidinedione is appropriate1.

Vildagliptin should be used with caution in patients with end stage renal disease on hemodialysis due to limited experience in this population1. If pancreatitis is suspected, vildagliptin and other potentially suspect medicinal products should be discontinued1. Vildagliptin should not be used in patients with hepatic impairment and in patients with coronary heart failure and is not recommended for use in children and adolescents1.

Since becoming available, vildagliptin has been shown to be generally well tolerated and effective in more than 15,000 vildagliptin-treated patients as part of a large clinical development program7 and the total patient-year exposure with vildagliptin is nearly two and a half million patient-treatment years7.

Galvus® is the registered trademark of Novartis AG.

References

1. GALVUS Summary of Product Characteristics (SmPC) for European Union.
2. Blicklé JF et al. Diabetic nephropathy in the elderly. Diab & Metabol 2007;33:S40-S55.
3. Cavanaugh KL. Diabetes management issues for patients with chronic kidney disease. Clin Diabetes 2007;25(3):90-97.
4. International Diabetes Federation. New IDF data reveals diabetes epidemic continues to escalate. http://www.idf.org/new-idf-data-reveals-diabetes-epidemic-continues-escalate Last accessed September 29, 2011.
5. Czekalski S. Diabetic nephropathy and cardiovascular disease. Rocz Akad Med Bialymst. 2005:50122-5.
6. Lukashevic V et al. Safety and efficacy of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal impairment: A prospective 24-week randomized placebo controlled trial. Diab, Obes and Metab 2011;13:947-954.
7. Novartis data on file.