Veloxis Pharmaceuticals A/S said the U.S. Food and Drug Administration approved its medicine Envarsus XR to prevent organ rejection in new kidney transplant patients.

Envarsus XR, an extended-release tablet form of tacrolimus, is an immunosuppressant, a drug which lowers the body's ability to reject a transplanted organ.

The approval is for a new indication, which will allow use of the drug, in combination with other immunosuppressants, to prevent organ rejection in de novo kidney transplant patients — meaning patients can receive the drug following transplant surgery.

Envarsus XR was previously approved, in combination with other anti-rejection drugs, to prevent organ rejection in kidney transplant patients who switched from other immediate-release formulations of tacrolimus.

Denmark-based Veloxis said the approval was based on positive results from a phase 3 trial which evaluated Envarsus against Astellas Pharma Inc.'s Prograf in 543 de novo kidney transplant patients.

Envarsus met the main goal of the trial, a measurement treatment failure — defined by biopsy-proven acute rejection, graft failure and death.

Results show that after a treatment period of one year, Envarsus, taken once a day, had a failure rate of 18.3% compared to a 19.6% failure rate for Prograf, taken twice a day.

Veloxis develops and sells products used in transplantation and adjacent therapies.