The US Food and Drug Administration has approved Bristol-Myers' Nulojix, which is a drug that prevents organ rejection in kidney transplant patients.
The new drug is to be used with other immunosuppressive drugs such as basiliximab, mycophenolate mofetil, and corticosteroids. Nulojix belongs to a class of drugs called selective T-cell costimulation blockers.
These drugs prevent the body from rejecting the newly transplanted kidney. The FDA approval follows the successful completion of two Phase-3 studies that included more than 1,200 patients. These studies compared two dose regimens of Nulojix with another immunosuppressant, cyclosporine.
Nulojix is an effective drug, but also carries a boxed warning regarding a risk of post-transplant lymphoproliferative disorder (PTLD), which is a type of cancer of the white blood cells.