NULOJIX (belatacept), selective immunosuppressant
IMMUNOLOGY - Update
Opinions on drugs - Posted on Mar 06 2017
Reason for request
Re-assessment of the improvement in actual benefit
Maintenance of minor clinical added value in prophylaxis of graft rejection in renal transplant in non-immunised patients with an immunological status positive for Epstein-Barr virus.
- NULOJIX, in combination with corticosteroids and mycophenolic acid (MPA), has Marketing Authorisation for prophylaxis of graft rejection in adults receiving a renal transplant.
- New data have confirmed reduced impairment of renal function with belatacept relative to ciclosporin at 7 years. However, there are less nephrotoxic alternatives and there is still an increased risk of acute rejection with belatacept relative to ciclosporin.
- The available data do not permit differentiating between belatacept and tacrolimus in terms of efficacy and safety.
Clinical Added Value
Évaluation des médicaments