Novartis gets positive CHMP opinion for Eucreas; presents new data at EASD

Swiss drugs major Novartis is expecting approval from the European Commission before the end of the year to market Eucreas, its fixed-dose oral combination of the DPP-4 inhibitor Galvus (vildagliptin) and the current gold-standard treatment for type 2 diabetes, metformin. A positive opinion was received on September 21 from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP). Novartis previously received a positive opinion for Galvus itself in the summer (Marketletter July 30).

Although Novartis has been beaten to the European market by Merck Sharp & Dohme (a part of US drug major Merck & Co), whose DPP 4 inhibitor Januvia (sitagliptin) is already available, the Swiss firm claims it will be the first to marked a fixed-dose single oral tablet containing both a DPP-4 inhibitor and metformin. The fixed-dose version of sitagliptin and metformin (Janumet) is marketed in the USA but is not yet available in Europe.

Novartis will market Eucreas in two strengths: vildagliptin 50mg plus metformin 850mg; and vildagliptin 50mg plus metformin 1,000mg. Both strengths will be administered twice daily. The fixed dose has greater importance in Europe, where approval of DPP-4 inhibitors is for their use in combination with either metformin, thiazolidinediones or sulphonylureas. Elsewhere Galvus, and Merck's product Januvia, can be prescribed as monotherapy. Novartis received a second "approvable" letter for Galvus from the US Food and Drug Administration earlier this year (Marketletter March 5) but has been asked to provide clinical trial data showing how the drug will affect patients with moderate or severe renal impairment. Trials have been designed and will begin once the FDA gives the go ahead.