On 21 May 2024, Johnson & Johnson announced results of the GALAXI 2&3 clinical studies of patients with moderate to severe Crohn’s Disease (CD).  The study, sponsored by Janssen Research & Development, showed that Tremfya® (guselkumab) resulted in significant improvements on a number of endoscopic endpoints when compared to both Stelara® (ustekinumab) and placebo.

As previously reported, J&J is seeking EMA approval to expand its marketing authority for Tremfya® to include treatment of adult patients with moderate to severe UC and moderate to severe CD.

On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC).  The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients receiving Tremfya® (guselkumab) achieved clinical remission at 44 weeks compared to placebo-treated patients.   

Tremfya® is currently approved in the US and Europe for treatment of severe plaque psoriasis and psoriatic arthritis.  In March 2024, Johnson & Johnson submitted an sBLA to the FDA for Tremfya® for moderately to severely active ulcerative colitis.  This is part of a strategy to expand into inflammatory bowel disease indications. 

On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.  This follows news of its US sBLA submission on 11 March 2024 for guselkumab for the treatment of moderately to severely active ulcerative colitis.

Tremfya® (guselkumab) is approved in Europe for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application (sBLA) for TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis.  The product is currently approved in the US to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis.

Janssen published data from Ph III trials of Tremfya® (guselkumab) for the treatment of psoriatic arthritis.  Janssen reported that early skin and enthesitis responses predicted longer-term clinical response, including disease remission at week 52.

Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis.  Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a higher clinical remission rate than induction and maintenance treatment with either guselkumab alone or golimumab alone.

Janssen released data from a Ph 2a clinical trial of guselkumab and golimumab in ulcerative colitis.  Janssen reported that the combination induced higher rates of clinical response, clinical remission, endoscopic improvement and a composite histologic-endoscopic endpoint at 12 weeks that either treatment alone.

The UK’s NICE recommended Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis and psoriatic arthritis.

Janssen announced that the European Commission has approved Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis.

Janssen announced that the CHMP has adopted a positive opinion recommending the expanded use of Tremfya® (guselkumab) to include the treatment of adult patients with active psoriatic arthritis.

Janssen announced that the FDA has approved Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis.