Veloxis says CHMP backs Envarsus

Veloxis Pharmaceuticals A/S (CSE:VELO) said EMA's CHMP backed approval of an MAA for Envarsus tacrolimus (formerly LCP-Tacro) to prevent organ rejection in kidney and liver transplant patients. An NDA for the product -- a once-daily tablet formulation of tacrolimus delivered using Veloxis' MeltDose technology -- is also under FDA review, with an Oct. 30 PDUFA date. ...