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Johnson & Johnson's Tremfya recommended by CHMP to treat Crohn's disease - PMLiVE
A CHMP recommendation is a major regulatory step toward EU approval — that could mean a new biologic option (guselkumab/Tremfya) for adults with moderate–severe Crohn’s disease, including people who haven’t responded to other treatments.
The drug’s IV and SC induction options and comparative phase 3 results versus ustekinumab are particularly relevant to treatment decisions.
Adults with moderate–to–severe Crohn’s disease, patients who have failed or are intolerant to other biologics or conventional therapies, gastroenterologists and IBD clinicians, and researchers following new biologic treatments.
What To Know
CHMP recommends approval of Tremfya (guselkumab) for moderately to severely active Crohn’s disease in adults who failed or were intolerant to conventional therapy or a biologic. The recommendation follows recent US FDA approval and phase 3 data from the GALAXI and GRAVITI programmes; the EC will make a final decision next.
The article notes Tremfya offers both IV and SC induction options and highlights comparative endoscopic results versus ustekinumab in GALAXI 2 and 3.
Tremfya is an IL-23 inhibitor already approved in the EU for some psoriasis and psoriatic arthritis cases; the CHMP opinion would expand its labelled use to include Crohn’s disease if the European Commission grants final approval.
The company also recently received a CHMP recommendation for Tremfya in ulcerative colitis and the US FDA approved it for Crohn’s disease the week before this article.
If approved by the EC, this could add another biologic option for adults with moderate–severe Crohn’s disease, including both IV and subcutaneous induction routes — details such as exact dosing schedules, access timelines, reimbursement, and how clinicians might position it relative to other biologics will depend on regulatory labeling and payer decisions.
This article reports a CHMP positive opinion, not a final European Commission approval; timelines for availability and reimbursement vary by country. The findings referenced come from phase 3 trials (GALAXI and GRAVITI) and comparative endoscopic endpoints versus ustekinumab — readers should consult regulatory labels and clinicians for treatment decisions.