Veloxis announced that the Food and Drug Administration (FDA) has approved Envarsus XR (tacrolimus extended-release) tablets for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR.

The approval of Envarsus XR was based on two Phase 3 trials and several Phase 2 trials in kidney transplant recipients. Across all trials, once-daily Envarsus XR showed significantly higher bioavailability and a flatter pharmacokinetics profile vs. twice-daily Prograf (tacrolimus immediate-release; Astellas Pharma).

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Tacrolimus is a calcineurin-inhibitor immunosuppressant that inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Tacrolimus prolongs the survival of the host and transplanted graft in animal transplant models of liver, kidney, heart, bone marrow, small bowel and pancreas, lung and trachea, skin, cornea, and limb.

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