Nulojix (belatacept), a drug designed to be taken with other immunosuppressants, has been approved by the FDA (Food and Drug Administration) to prevent acute rejection of donated kidneys in transplant recipient adults. Nulojix has been approved as adjunct therapy to be taken with basiliximab, mycophenolate mofetil, and corticosteroids.

Nulojix is a selective T-cell costimulation blocker. Without immunosuppressant drugs the body may reject a transplanted organ because the immune system treats it as a pathogen – a foreign body that produces disease and needs to be destroyed.

Nulojix is administered via 30-minute intravenous infusions.

Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, 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.”

The FDA evaluated two open-label, randomized, multicenter, controlled Phase 3 trials involving 1,200 patients. Two dose regimens of Nulojix were compared to cyclosporine, another immunosuppressant medication.

The studies showed that Nulojix is safe and effective in the prevention acute kidney rejection.

A Boxed Warning explains that there is a higher chance of developing PTLD (post-transplant lymphoproliferative disorder) when patients take Nulojix. PTLD is a disorder in which a group of B-cells grow uncontrollably following an organ transplant in patients whose immune systems are weak. Typically, the patient is also infected with Epstein-Barr virus (EBV). PTLD can progress to non-Hodgkin lymphoma, which is also called PTLD. Non-Hodgkin lymphoma are malignant tumors (cancer) that develop in the lymphatic system.

PTLD risk is greater for transplant recipients who have never been exposed to EBV, which causes an increase of monocytes – mononucleosis.

If a patient has never been exposed to EBV, their body finds it harder to mount a proper immune response to the virus if infection occurs following a transplant. In most cases, the patient is exposed to the virus during the transplantation procedure – it exists within approximately 80% of donated organs.

Only patients who have been exposed to EBV should be allowed to receive Nulojix. Tests can find that out.

Another Boxed Warning informs patients and doctors of a higher risk of developing some other cancers and serious infections.

These were the most common adverse reactions reported from the trials: anemia, bladder infection, kidney infection, edema in the legs, ankles or feet, and constipation. Patients should limit exposure to sunlight due to a higher skin cancer risk. They should also avoid live vaccines.

According to the Organ Procurement and Transplantation Network, nearly 90,000 Americans are waiting for a kidney transplant.

Bristol-Myers Squibb markets Nulojix.

Lamberto Andreotti, Chief Executive Officer, Bristol-Myers Squibb, said:

“The approval of NULOJIX exemplifies our company’s commitment to innovate in the areas of serious disease and biologics drug development.”

Written by Christian Nordqvist