Novartis drug Galvus® approved in EU for monotherapy use in patients with type 2 diabetes unable to take metformin

Novartis announced today that the European Commission has approved the use of Galvus® (vildagliptin) in patients with type 2 diabetes unable to control their blood sugar with diet and exercise alone and who cannot take metformin, the current standard of care4,5. Galvus is already approved in the EU as an add-on to metformin for patients with type 2 diabetes3.

There are more than 47 million people with type 2 diabetes in Europe and this figure is projected to rise to 57 million by 20306,7. A quarter of patients with type 2 diabetes being treated cannot take metformin due to intolerance or contraindications, including those with renal impairment1,2.

“Today’s approval for Galvus as a monotherapy provides the millions of patients unable to take metformin with an effective and generally well-tolerated alternative,” said Timothy Maloney, Global Business Franchise Head, Primary Care, Novartis. “Novartis is committed to providing innovative treatments where there is a clear patient need.”

Approval is based on data from clinical studies in more than 3,000 patients, which have assessed the efficacy and tolerability of vildagliptin as monotherapy5. In these studies, vildagliptin delivered significant improvements in glycemic control and was shown to be generally well-tolerated5. Vildagliptin was demonstrated to be weight neutral and to be associated with a very low risk of hypoglycemia5.

About Galvus®

Galvus® (vildagliptin) is approved in more than 90 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 insulin. Specific indications vary by country.

Since becoming available, Galvus has been shown to be generally well-tolerated in more than 11,500 patients as part of a large clinical development program and the total post-marketing exposure is nearly two and a half million patient-treatment years5.

In clinical trials the majority of adverse events reported have been mild and transient, not requiring treatment discontinuations3. No severe hypoglycemic events have been reported in the Galvus arms of clinical studies3. In rare cases of hepatic dysfunction following treatment with Galvus, patients were generally asymptomatic and liver function returned to normal after discontinuation of treatment3. Vildagliptin should not be used in patients with hepatic impairment3. Pancreatitis has been reported in post-marketing experience3.

References

1. Blicklé JF et al. Diabetic nephropathy in the elderly. Diab & Metabol 2007;33:S40-S55.
2. Metformin Summary of Product Characteristics (SmPC) for the European Union.
3. Galvus Summary of Product Characteristics (SmPC) for the European Union.
4. Senior PA. Type 2 diabetes, metformin and lactic acidosis – defining the risk and promoting safe practice. Diab Med. 2011;doi:0.1111/j.1464/5491.2011.03469.x.
5. Novartis data on file.
6. International Diabetes Federation. Diabetes Atlas Fifth Edition: Europe (EUR). http://www.idf.org/diabetesatlas/5e/europe. Accessed January 12, 2012.
7. International Diabetes Federation. Types of diabetes. http://www.idf.org/types-diabetes. Accessed January 12, 2012.