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Johnson & Johnson's Tremfya recommended by CHMP to treat Crohn's disease - PMLiVE
Medications
Guselkumab
Ustekinumab
IL-23 inhibitor
IL-12/23 inhibitor
Abdominal Pain
Rectal Bleeding
Weight Loss
Why This Matters
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.
Who Should Pay Attention
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.
Study Snapshot
Story typeResearch news
Evidence typeRegulatory update
Source depthFull source text
What To Know
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.
Keep In Mind
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.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Article type assigned from Cure8 classification; confirm details in the original source.
Publicationpmlive.com
Indexed viaGoogle News
Source typeResearch news
PublishedMar 31, 2025, 11:26 AM
Content availableFull source text
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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