J&J nixes Tremfya trial in giant cell arteritis
SPRING HOUSE, Pa., June 20, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.1 The study met both co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission at Week 12 as well as endoscopic response at Week 12. All remaining multiplicity-controlled endpoints at Week 12, Week 24 and Week 48 were statistically significant compared to placebo. GRAVITI adds to the robust results demonstrated in GALAXI 2 and GALAXI 3, the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus STELARA® (ustekinumab) in key endoscopic endpoints in Crohn's disease, which together show the potential of TREMFYA® to become the only IL-23 inhibitor to offer both SC or IV induction options.3,4 Safety data from GRAVITI were consistent with the well-characterized safety profile of TREMFYA® in its approved indications.
Innovent’s psoriasis contender to IL-23 drugs like Tremfya and Skyrizi cleared skin in a phase 3 test, setting up an approval request in China.
J&J’s Tremfya trumps placebo, Stelara in Phase III Crohn`s trial
WASHINGTON, May 21, 2024 /PRNewswire/ -- Johnson & Johnson today announced the first Phase 3 results for TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn's disease (CD), which demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) versus placebo and ustekinumab.1 Data showed that both maintenance doses of TREMFYA® met the composite co-primary endpoints compared to placebo in each individual study.1,b In results versus ustekinumab, both doses of TREMFYA® demonstrated statistically significant and clinically meaningful differences on all prespecified pooled endoscopic endpoints.1 These findings were featured as a late-breaking oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024.1
WASHINGTON, May 20, 2024 /PRNewswire/ -- Johnson & Johnson today announced the first data from the Phase 3 QUASAR Maintenance Study (Abstract #759) that showed 50.0 percent (p<0.001) of patients with moderately to severely active ulcerative colitisa (UC) receiving subcutaneous (SC) TREMFYA® (guselkumab) 200 mg every four weeks (q4w) and 45.2 percent (p<0.001) of patients receiving SC TREMFYA® 100 mg every eight weeks (q8w) achieved the primary endpoint of clinical remissionb at Week 44 compared to placebo (18.9 percent).1 In additional analyses of patients who were in clinical remission, 67 percent and 71 percent, respectively, were also in endoscopic remission at Week 44 (Mayo endoscopic subscore [MES]= 0), indicating they had normal appearance of intestinal mucosa.2
J&J's Tremfya is the latest biologic to throw its hat in the ulcerative colitis ring, following rival drugs from Eli Lilly and AbbVie.
BEERSE, Belgium, May 1, 2024 /PRNewswire/ -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application 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.
J&J submits supplemental BLA to U.S. FDA seeking approval of TREMFYA
HORSHAM, Pa., Jan. 22, 2024 /PRNewswire/ -- Johnson & Johnson today announced that TREMFYA® (guselkumab) demonstrated rapid and significant clearance in moderate to severe scalp psoriasis (PsO) and significant improvement in scalp itch, as well as patient-reported health-related quality of life outcomes, including post-inflammatory pigmentation at 16 weeks. Topline data from Cohort B in the Phase 3b VISIBLE study were presented today at the Maui Derm Hawaii 2024 conference.