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TREMFYA receives positive CHMP opinion for treatment of patients with Crohn's
If approved, TREMFYA (guselkumab) could become an additional IL‑23 inhibitor option for adults with moderate‑to‑severe Crohn’s disease, including both IV and SC induction dosing. That may affect treatment choices for people who did not respond to or could not tolerate prior therapies.
Adults with Crohn’s disease (especially those with inadequate response to conventional therapy or biologics), clinicians treating IBD, and researchers tracking new biologic approvals.
What To Know
CHMP (EMA committee) has given a positive opinion recommending expansion of TREMFYA (guselkumab) to treat adults with moderately to severely active Crohn’s disease who failed or were intolerant to conventional therapy or a biologic.
The recommendation was based on Phase 3 GALAXI and GRAVITI programme results reporting co‑primary endpoints (clinical remission and endoscopic response at Week 12) and longer-term endoscopic response and corticosteroid‑free remission at Week 48 versus placebo; pooled results reportedly showed greater endoscopic efficacy versus ustekinumab at Week 48.
The application included both IV and SC induction dosing options. This opinion now goes to the European Commission for a final decision on extending the marketing authorisation in the EU. Safety results were described as consistent with the known guselkumab profile in other approved uses.
The article is a pharma/industry report of the CHMP opinion and Phase 3 study outcomes and does not provide full trial data or regulatory text.
This is a CHMP positive opinion (an important regulatory step) based on company‑reported Phase 3 programmes; the European Commission must still issue a final decision. The article summarizes study outcomes but does not include full trial data, safety details, or regulatory conditions of approval.
