Friday, June 17, 2011

FDA approves Belatacept (NULOJIX) for use in kidney transplantation.

It’s been a long time since the FDA approved a new drug fortransplantation which makes this news very exciting.  On June 16th Bristol-Myers Squibbannounced that the FDA approved the use of NULOJIX (Belatacept) for use inkidney transplantation as an induction and maintenance agent in combinationwith mycophenolate mofetil and corticosteroids. The FDA reviewed the Benefit and Benefit EXT trials prior to coming to theirconclusion. 
Belatacept is a selective T-cell co-stimulation blocker thatis administered IV which offers comparable results to cyclosporine.  Though the acute rejection rate seems to beslightly higher with Belatacept than cyclosporine, trials reveal a higher GFR inthe Belatacept arms at 3 years of follow up. The obvious hope is that the use of Belatacept will avoid calcineurininhibitor nephrotoxicity in kidney transplant recipients improving long termallograft outcome.  The major concern withBelatacept is an increased risk for PTLD seen in many of the trials.  For this reason it is contraindicated in EBVseronegative patients or patients with unknown EBV serostatus.  To address the concern of PTLD Bristol-MyersSquibb established the ENLiST Registry. The registries purpose is to determine the incidence of PTLD, CNS PTLD,and PML in US adult EBV seropositive kidney transplant recipients treated withBelatacept.
Belatacept is administered IV over 30 minutes and the recommendeddosing is 10 mg/kg on the day of transplantation then on day 5, then at the endof weeks 2, 4, 8, and 12. After week 16 it is recommended that the maintenancedose be 5 mg/kg every 4 weeks.

by Dr. Vinay Nair

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