The drug demonstrated safety profile and positive results when investigated in open-label, randomized, multicenter, controlled Phase 3 studies comparing two dose regimens of Nulojix with another immunosuppressant cyclosporine.
The drug was safe and effective in prevention of acute organ rejection.
FDA Center for Drug Evaluation and Research Office of Antimicrobial Products director Edward Cox said Nulojix is a new option for kidney transplant patients.
"This new medication used in combination with other immunosuppressants helps control the immune system and prevents organ rejection in patients receiving kidney transplants," Cox said.