EU approval for added use of Novartis diabetes drug Galvus

The European Commission has approved Swiss drug major Novartis’ (NOVN: VX) Galvus (vildagliptin) (50mg once a day) for the treatment of type 2 diabetes patients with moderate or severe renal impairment.

Galvus, which generated third-quarter 2011 sales of $181 million for the company in its present indications, is currently available for patients with no or mild renal impairment and this approval expands treatment options for patients with moderate or severe renal impairment.

Renal impairment affects around one quarter of the 366 million people worldwide with diabetes and is a major cause of death in this population. 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 caution. As a result, physicians have few treatment options3 for these high-risk patients5.