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." |
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