EC approves Veloxis' Envarsus

The European Commission approved Envarsus tacrolimus from Veloxis Pharmaceuticals A/S (CSE:VELO) to prevent organ rejection in adult kidney and liver transplant patients. Veloxis said partner Chiesi Farmaceutici S.p.A. (Parma, Italy) plans to launch the product -- a once-daily tablet formulation of tacrolimus delivered with Veloxis' MeltDose technology -- in the EU late this year. Envarsus is also under FDA review to prevent organ rejection in kidney transplant patients, with an Oct. 30 PDUFA date. ...