Veloxis Pharmaceuticals A/S last week announced the U.S. Food and Drug Administration approved Envarsus XR for the prophylaxis of rejection in kidney transplant patients who require or want change from other twice-daily tacrolimus products to once-daily Envarsus XR.
Veloxis expects Envarsus XR to be available to patients in the U.S. and their physicians in the fourth quarter of 2015.
"We are very pleased to have a new treatment option available for kidney transplant recipients," Anthony Langone, associate professor and medical director of the Medical Specialties Clinic at Vanderbilt University, said. "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."
The FDA marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients.
"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,” Veloxis CEO Bill Polvino 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."