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FDA approves Envarsus XR to prevent kidney transplant rejection
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The U.S. Food and Drug Administration has approved Envarsus XR (tacrolimus extended-release tablets) to prevent rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR.
Manufacturer Veloxis said they expect Envarsus XR to be available to patients in the United States on the fourth quarter of 2015.
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Envarsus XR is an extended release formulation of tacrolimus designed for once-daily dosing.The FDA marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients.
"We are now aggressively moving forward with completing the buildup of our commercial organization as planned, including the recruitment of our sales force who will promote Envarsus XR to transplant physicians in the U.S. We look forward to making Envarsus XR available to patients later this year," said Bill Polvino, chief executive officer of Veloxis said. -by Rebecca Zumoff