Please login to the form below

Not currently logged in

Novartis’ Galvus gains monotherapy licence in Europe

Type 2 diabetes treatment now available for patients who cannot take metformin

Novartis' type 2 diabetes drug Galvus (vildagliptin) has extended its European license to add a monotherapy indication.

The drug is now available for patients who cannot take metformin and who are unable to control their blood sugar with diet and exercise alone.

Previously the drug had only been available in combination with other treatments, such as metformin, a sulphonylurea (if metformin is inappropriate) or a thiazolidinedione in patients with insufficient glycaemic control.

This new indication means Galvus offers greater competition to Merck & Co's fellow DPP-IV inhibitor Januvia (sitagliptin), which is also approved as a monotherapy and is the current market leader in its class.

The drugs work by blocking production of the enzyme DPP-IV, which plays a major role in glucose metabolism.

Other DPP-IV inhibitors include Bristol-Myers Squibb/AstraZeneca's Onglyza (saxagliptin), although the drug is currently only approved as an add-on therapy in Europe.

The new Galvus approval gives people with type 2 diabetes who are unable to take metformin due to intolerance or contraindication an alternative treatment option.

According to Novartis, this accounts for a quarter of Europe's 47m type 2 diabetes patients.

The approval was based on clinical studies involving more than 3,000 patients that demonstrated patients taking Galvus had improved glycaemic control and was well-tolerated by patients.

In the last few months, the drug has gained European approval to treat patients with type 2 diabetes who have either moderate or severe renal impairment.

It was also approved in China, where the country's diabetes population is approaching 100m people, in January, 2012, as an add-on treatment to metformin.

However, Galvus still has no licence 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.

7th February 2012


Featured jobs

Subscribe to our email news alerts


Add my company
mXm Medical Communications

mXm Medical Communications meets the needs of pharmaceutical marketers and medics who require a highly experienced, bespoke service from their...

Latest intelligence

What is a patient-centric brand anyway?
It’s hard to believe that in our industry, there have been ongoing rumblings about patient-centricity for years now. Sure, there are some great companies who have worked hard to bring...
‘Less Is More: Making Patient-Centered Digital Communication a Reality’
Letizia Affinito writes on the Gower Publishing blog....
The Seven Cs Of Cross-Functional Brand Planning
As more and more organisations have moved to cross-functional and cross-regional involvement in the development of their strategic and operational brand plans, the result has been greater engagement and alignment,...