FDA Approves Treatment for Kidney Transplant Patients

Envarsus protects against organ rejection in transplant patients who switch from other twice-daily tacrolimus products.

The FDA on Monday approved a new therapeutic option for kidney transplant patients.

Envarsus XR is a once-daily tacrolimus extended-release tablet that protects against organ rejection in kidney transplant patients who require conversion from other twice-daily tacrolimus products. Envarsus is expected to be available in the United States by the fourth quarter of 2015.

Envarsus XR offers an extended release formulation of tacrolimus with flatter pharmacokinetics (PK) and greater bioavailability compared with twice-daily tacrolimus, according to manufacturer Veloxis Pharmaceuticals.

The FDA approval followed a pair of phase 3 trials and several phase 2 trials in kidney transplant patients. In all of the trials, once daily Envarsus showed significantly higher bioavailability and a flatter PK profile than current leading transplant drug Prograf (immediate release tacrolimus) dosed twice-daily.

"We are very pleased to have a new treatment option available for kidney transplant recipients," Anthony Langone, MD, associate professor and medical director of the Medical Specialties Clinic at Vanderbilt University said in a press release. "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."