Reason for request

Extension of indication


Clinical Benefit



Clinical Added Value

no clinical added value

" In view of :

- the efficacy and safety data versus placebo,

- the absence of direct comparative data versus other anti-ANF agents, particularly infliximab,

the Transparency Committee considers that SIMPONI (golimumab) does not provide any improvement in actual benefit (IAB V, non-existent) in the treatment of moderately to severely active UC which is resistant to conventional therapies."