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Novartis’ Galvus gets new European approval

Diabetes drug licensed for use in type 2 patients with moderate or severe renal failure

Novartis' diabetes drug Galvus (vildagliptin) has won European approval for a new indication.

The European Commission (EC) approved DPP-4 inhibitor Galvus to treat type two diabetic patients with either moderate or severe renal impairment.

This is when the kidneys fail to filter toxins and waste products from the blood and can be a common cause of death in people with diabetes

Galvus was previously limited to diabetic patients who had either no or just the mild forms of the condition.

While many treatments are contraindicated or have to be used with caution, due to the complex system of blood sugar levels in these patients, Galvus is not the first drug in its class to extend its licence in this way.

In March AstraZeneca and Bristol-Myers Squibb's Onglyza (saxagliptin) became the first DPP-4 inhibitor to win a European licence to treat type 2 diabetes patients who have moderate or severe renal impairment.

More recently, Boehringer-Ingelheim and Lilly's Trajenta (linagliptin), which can also be used in patients with renal impairment, was approved in Europe in August.

Timothy Maloney, global business franchise head, primary care at Novartis, said: “This approval provides physicians with a much-needed new treatment to control blood sugar in a vulnerable patient population whose management is highly challenging.”

The Galvus was approved based on results of a phase III trial involving 515 patients over 24 weeks to assess the safety of the treatment in patients with type 2 diabetes and moderate or severe renal impairment.

Galvus was demonstrated to have a similar safety profile as placebo in the trial, and resulted in significant improvements in control of blood sugar when added to an existing anti-diabetic therapy. Galvus is approved for use with metformin, a sulphonylurea or thiazolidinedione depending on what drug is most appropriate for the patient.

Professor Per-Henrik Groop, Helsinki University Central Hospital, one of the study's investigators, said: “The data supporting this approval demonstrate that with vildagliptin good tolerability can be achieved without compromising on efficacy.”

Galvus has yet to be licensed in the US in any indication, after Novartis withdrew its application to the Food and Drug Administration in 2008 due to the regulator's demands for additional clinical data.

6th December 2011

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