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FDA approves BMS' kidney rejection drug

The US FDA has approved Bristol-Myers Squibb’s Nulojix to prevent acute rejection in adult patients who have had a kidney transplant

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's (BMS) Nulojix (belatacept), a selective T-cell costimulation blocker, to prevent acute rejection in adult patients who have had a kidney transplant.

The drug is approved for use with other immunosuppressants specifically basiliximab, mycophenolate mofetil and corticosteroids.

"Nulojix is a new option for kidney transplant patients," said Dr Edward Cox, director of office of antimicrobial products in the FDA's Center for Drug Evaluation and Research. 

"This new medication used in combination with other immunosuppressants helps control the immune system and prevents organ rejection in patients receiving kidney transplants."

Results from two controlled Phase III, open-label, randomised, multicentre studies that included more than 1,200 patients and compared two dose regimens of Nulojix with another immunosuppressant, cyclosporine, demonstrated that the recommended Nulojix regimen is safe and effective for the prevention of acute organ rejection.

Nulojix carries a Boxed Warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD), a type of cancer where white blood cells grow out of control after an organ transplant. Transplant patients who have never been exposed to Epstein-Barr virus (EBV) have a higher risk of developing PTLD.

Several immunosuppressants, including Nulojix, also carry another Boxed Warning covering the increased risk of serious infections and other cancers.

16th June 2011

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