pmlive.com
Johnson & Johnson’s Tremfya recommended by CHMP to treat Crohn’s disease
A CHMP positive opinion means guselkumab (Tremfya) could become an approved treatment option for adults with moderately to severely active Crohn’s disease in the EU, offering both IV and SC induction routes. This could expand options for people who have not responded to or tolerated other therapies.
Adults with Crohn’s disease who have failed conventional or biologic therapies, patients on biologics considering treatment-switching, gastroenterologists, and IBD researchers.
What To Know
The CHMP has given a positive opinion recommending 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 article notes Tremfya offers both intravenous and subcutaneous induction options and that the recommendation follows recent US FDA approval supported by phase 3 GALAXI and GRAVITI programme data, including comparisons versus ustekinumab.
What this appears to report: a regulatory recommendation (CHMP positive opinion) for expanding guselkumab’s EU indication to include Crohn’s disease, with the European Commission to make the final decision. It also mentions prior approvals in psoriasis and psoriatic arthritis and a recent CHMP recommendation for ulcerative colitis.
How patients might read this: it’s news about a potential new treatment option becoming available in Europe pending final approval.
The story does not provide prescribing guidance, eligibility criteria beyond the general classes of prior treatment failure/intolerance, or detailed safety information; decisions about treatment should remain between a patient and their clinician.
Source reliability note: this item is a pharma/industry news report summarising regulatory actions and trial programme names; for clinical decisions or detailed efficacy/safety data, consult the published trial reports, product labelling, or your treating clinician.
This is a regulatory recommendation (CHMP positive opinion); the European Commission makes the final decision. The article references phase 3 programmes (GALAXI and GRAVITI) and a recent US FDA approval but does not provide detailed efficacy or safety data. It does not change clinical care immediately without final EU approval and local reimbursement decisions.