Bristol-Myers Squibb Co. (BMY) announced new 4-year results from the long-term extensions or LTE of the BENEFIT and BENEFIT-EXT clinical trials of NULOJIX (belatacept), the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult Epstein-Barr Virus or EBV seropositive patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil or MMF, and corticosteroids.
The company said that the results showed that the safety profile of NULOJIX through year 4 was consistent compared with results at year 3 with no new safety signals being identified, and that the renal function benefit versus cyclosporine was maintained through 4 years in patients enrolled in the LTE from both the BENEFIT and BENEFIT-EXT trials.
NULOJIX was approved by the U.S. Food and Drug Administration or FDA in June 2011 for the prophylaxis of organ rejection in adult EBV seropositive patients receiving a kidney transplant (not for transplanted organs other than the kidney), in combination with basiliximab induction, MMF, and corticosteroids.
FDA approval was based on data from BENEFIT and BENEFIT-EXT -- two 3-year, phase 3, open-label, randomized, multicenter, active-controlled studies.
The most serious adverse reactions reported with NULOJIX are post-transplant lymphoproliferative disorder (PTLD), predominantly CNS PTLD, and other malignancies, as well as serious infections, including JC virus-associated PML (often a rapidly progressive and fatal opportunistic infection) and polyoma virus nephropathy. Due to increased risks, including PTLD and PML, higher than recommended doses or more frequent dosing of NULOJIX (belatacept) is not recommended.
The NULOJIX MI regimen is not recommended for patients taking NULOJIX as it may result in higher incidence of serious—sometimes fatal—adverse reactions, including serious infections, overall malignancies and death.
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