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European recommendation for Galvus' monotherapy license

CHMP issues positive opinion for Novartis' diabetes drug

Novartis has won backing from European regulatory advisers for a monotherapy licence for its type II diabetes drug Galvus (vildagliptin).

This would allow the drug to be used on its own in patients whose diabetes is inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on extending the drug's current licence as a dual oral therapy.

At the moment it can only be used in combination with metformin, a sulphonylurea (if metform is inappropriate) or a thiazolidinedione in patients with insufficient glycaemic control.

CHMP positive opinions are normally passed as full European approval within three months, and would give a further boost to Galvus, which is also marketed in Europe under the brand names Jalra and Xiliarx.

The diabetes drug recently extended its licence in Europe, winning approval to treat type two diabetic patients with either moderate or severe renal impairment.

19th December 2011

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