Envarsus® XR is an extended release formulation of tacrolimus designed for once-daily dosing, with flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus. The FDA marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients. In all of the clinical trials, Envarsus® XR dosed once daily demonstrated significantly higher bioavailability and a flatter PK profile, compared to the current leading transplant drug, Prograf® (immediate release tacrolimus), dosed twice-daily.

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    Envarsus gets FDA Approval

    Veloxis Announces U.S. FDA Approval of Envarsus® XR for Treatment of Kidney Transplant Patients   Envarsus® XR is Indicated for Patients Converted from Tacrolimus Immediate-release Formulations  –   Envarsus® XR is Expected to be Available for Patients and Physicians in 4Q2015 Veloxis Pharmaceuticals A/S (OMX: VELO) today announced U.S. Food and Drug Administration (FDA) approval of Envarsus® XR (tacrolimus […]