Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Novasecta

We are a specialist strategy consulting firm for pharmaceutical and biotech companies. We help our clients to achieve significant performance...

Latest intelligence

OPEN Health Graduates and the XP Support Group
During our graduate induction period in September 2018, we were asked to find a charity that could benefit from the expertise of the OPEN Health practices. We made the decision...
Alexander Devine Website has gone live!
As part of the OPEN Health CSR programme one of the charities we support is Alexander Devine. They are a local Children's Hospice based in Maidenhead who provide a truly...
Drug pricing and competition
Strengthening business competition and reducing anti-competitive practices
How the CMA is tackling high prices for essential drugs...

Infographics