The EMA decided to extend the drug’s current licence as a dual oral therapy, taken in combination with metformin or (where necessary) with sulphonylurea or thiazolidinedione.
The licence extension would mean that Galvus, a DPP-4 inhibitor, can be used on its own in patients for whom non-drug measures are not effective and who cannot tolerate metformin.
The recommendation follows a previous license extension in Europe, allowing Galvus to be used to treat type 2 diabetes patients with renal impairment.
The drug’s recent success in Europe contrasts with its failure to gain FDA approval in 2008, due to concerns about its potential impact on liver function. Galvus is still not approved for use in the US.