CHMP recommends Envarsus for Organ Transplant Rejection - Veloxis Pharma

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of a marketing authorization for Envarsus (tacrolimus once daily), from Veloxis Pharmaceuticals, for the prevention of organ Rejection in adult Transplant patients in the European Union (EU). The positive opinion is for both kidney and liver transplant recipients and includes both the de novo transplant and �switch� settings, as well as for treatment of rejection episodes resistant to treatment with other immunosuppressive products in adult patients.

The assessment 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. The drug is filed with the FDA - the result is expected in October.