EC approves Envarsus for Kidney/Liver Transplant Rejection-Veloxis Pharma

The European Commission (EC) has granted marketing authorization for Envarsus (tacrolimus once daily), from Veloxis Pharmaceuticals, for the prevention of organ Rejection in adult Kidney and Liver Transplant patients in the European Union. The marketing authorization is based on review of the favorable results of the Envarsus Phase III 3001 study in stable kidney transplant patients and 3002 study in de novo kidney transplant recipients as well as data from an extensive Phase I and II clinical program, which included both kidney and liver transplant patients.

Studies 3001 and 3002 demonstrated that Envarsus dosed once-daily was not inferior to the current leading transplant drug, Prograf (tacrolimus), dosed twice-daily. The Phase I pharmacokinetic and Phase II efficacy data that was submitted in the MAA enabled extrapolation into the broader populations of both kidney and liver transplant recipients. Chiesi Farmaceutici, through an exclusive license and distribution agreement with Veloxis, will hold the Marketing Authorization and commercialize Envarsus in the European Union.