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Published on 8/17/2006 in the Prospect News Biotech Daily.

Novartis seeks European approval for once-daily Galvus for treatment of type 2 diabetes

By Lisa Kerner

Charlotte, N.C., Aug. 17 - Novartis AG submitted its new, once-daily oral therapy Galvus (vildagliptin) for European approval for the treatment of type 2 diabetes.

Galvus has demonstrated blood sugar lowering effects, even among patients who have poor glycemic control, are obese or older than 65, without associated weight gain, according to a company news release.

The therapy's novel mechanism of action targets the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes.

Novartis based its Galvus E.U. regulatory submission on a clinical development program containing data from more than 5,400 patients.

Galvus was accepted for U.S. regulatory review in March, the company said.

Novartis is a Basel, Switzerland, pharmaceutical company.


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