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7 Dec 2011

EU Grants Approval for Expanded Use of Galvus

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.

Novartis announced 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 impairment.

 

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.

 

The approval is based on the results of the largest study to date of a DPP-4 inhibitor in patients with renal impairment. The study assessed the safety and tolerability of vildagliptin (50 mg qd) in patients with type 2 diabetes and moderate or severe renal impairment. The trial showed that vildagliptin had a similar safety profile to placebo in these patients and resulted in significant improvements in glycemic contro

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