Veloxis Pharmaceuticals A/S (OMX: VELO) today announced U.S. Food and Drug Administration (FDA) approval of 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. Veloxis expects Envarsus® XR to be available to patients in the United States and their physicians in 4Q2015.
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.
"This is a proud moment for everyone at Veloxis and we appreciate the hard work by our study investigators and the participation of the patients in our studies," Bill Polvino, chief executive officer of Veloxis said. "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."
"We are very pleased to have a new treatment option available for kidney transplant recipients," said Anthony Langone, M.D., associate professor and medical director of the Medical Specialties Clinic at Vanderbilt University. "Patients must receive immunosuppression as lifelong therapy and Envarsus XR holds promise for kidney transplant patients and their physicians as a tacrolimus product with the convenience of once-daily dosing."
SOURCE Veloxis Pharmaceuticals A/S