Novartis: FDA accepts for review New Drug Application for Galvus to treat type 2 diabetes

By E. Janene Geiss

Philadelphia, March 30 - Novartis Pharmaceuticals Corp. said Thursday that the New Drug Application for Galvus (vildagliptin, formerly LAF237) was accepted for standard review by the Food and Drug Administration.

If approved, Galvus will provide a new, once-daily oral treatment option for people with type 2 diabetes, according to a company news release. Submission for approval in Europe is on track to be completed later in 2006.

Galvus, a DPP-4 inhibitor, works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes.

Galvus affects both pancreatic alpha and beta cells, leading to a reduction in sugar production from the liver together with an increase in production of insulin needed to keep blood sugar under control, officials said.

"The prevalence of diabetes is increasing and more than half of the people who are currently taking diabetes medications are still not reaching their blood sugar goals," James Shannon, head of development at Novartis, said in the release.

The submission includes data from clinical trials involving more than 4,300 patients worldwide evaluating the use of Galvus as monotherapy and also in combination with commonly prescribed anti-diabetic agents.

In clinical studies, Galvus has shown significant HbA1c reductions out to one year of treatment, with good overall tolerability and without causing weight gain. The most common side effects were cold-like symptoms, headache and dizziness.

Novartis Pharmaceuticals, based in East Hanover, N.J., develops, manufactures and markets prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. It is an affiliate of Novartis AG and Novartis Group based in Basel, Switzerland.

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