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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 Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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