TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to ... - PR Newswire
FDA approves TREMFYA®, the first dual-acting IL-23 inhibitor for active ulcerative colitis, showing significant endoscopic remission rates in QUASAR program. TREMFYA® is also approved for plaque psoriasis and psoriatic arthritis.
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J&J's Tremfya approved by FDA for treating adults with moderately to severely active ulcerative colitis. The drug, targeting IL-23, showed 50% and 45% clinical remission rates in patients receiving 200mg and 100mg doses, respectively, compared to 19% in placebo.
FDA approves Johnson & Johnson's Tremfya for adults with moderately to severely active ulcerative colitis. Tremfya, a dual-acting monoclonal antibody, blocks IL-23 and binds to CD64, improving chronic symptoms and normalizing intestinal lining. The drug is also approved for plaque psoriasis and psoriatic arthritis, with a cost of $14,618 per 100 mg/mL solution. Tremfya generated $3.1 billion in worldwide revenue in 2023, up 18% from 2022. J&J offers $5 per injection and $0 copay programs for eligible patients. The ulcerative colitis approval was based on the QUASAR study, showing significant clinical and endoscopic remission rates. J&J has also submitted an application for Tremfya to treat Crohn's disease, based on the GALAXI program results.
Tremfya (guselkumab) receives FDA approval for adults with moderately to severely active ulcerative colitis, offering significant improvement in symptoms and endoscopic remission.
FDA approves Johnson & Johnson's TREMFYA (guselkumab) for treating adults with moderately to severely active ulcerative colitis. TREMFYA, a fully human monoclonal antibody, blocks IL-23 and binds to CD64, showing efficacy and safety in Phase II/III QUASAR study. 50% of patients on 200mg every four weeks achieved clinical remission at week 44, significantly higher than placebo.
J&J secures FDA expanded approval for Tremfya (guselkumab) to treat ulcerative colitis, a chronic disease of the large intestine. Tremfya, a dual-acting monoclonal antibody, blocks IL-23 and binds to CD64, neutralising inflammation. The approval is supported by the Quasar Phase 2b/3 study, showing high rates of endoscopic remission at one year.
The FDA approved Johnson & Johnson’s guselkumab (Tremfya) for treating adults with moderately to severely active ulcerative colitis (UC), based on the QUASAR study. Guselkumab, a fully-human, dual-acting monoclonal antibody, induces clinical and endoscopic remission in UC patients with inadequate response or intolerance to conventional therapy, other biologics, and/or JAK inhibitors. In the QUASAR study, 50% of patients receiving guselkumab 200 mg every four weeks and 45% receiving 100 mg every eight weeks achieved clinical remission at week 44 compared to 19% on placebo.
The FDA approves Johnson & Johnson's Tremfya, an IL-23 inhibitor, for treating moderately to severely active ulcerative colitis, marking its third indication. Tremfya competes with AbbVie's Skyrizi in the UC market. The approval is based on the QUASAR trial, showing 50% of patients achieved clinical remission with Tremfya 200 mg every 4 weeks.
Johnson & Johnson's TREMFYA (guselkumab) approved by FDA for treating adults with moderately to severely active ulcerative colitis, marking its third indication. TREMFYA is the first fully-human, dual-acting monoclonal antibody blocking IL-23 and binding to CD64.
FDA approves Johnson & Johnson's Tremfya for ulcerative colitis, adding to its existing approvals for plaque psoriasis and psoriatic arthritis. Tremfya's potential to generate $5B in revenue is significant, especially as J&J's Stelara faces market exclusivity loss and price cuts. Competitors like AbbVie and Eli Lilly also have strong IBD treatments, intensifying the market competition.
FDA approves Johnson & Johnson's Tremfya (guselkumab) for moderately to severely active ulcerative colitis, based on QUASAR study results showing significant clinical and endoscopic remission rates.
FDA approves TREMFYA®, the first dual-acting IL-23 inhibitor for active ulcerative colitis, showing significant endoscopic remission rates in QUASAR program. TREMFYA® is also approved for plaque psoriasis and psoriatic arthritis.
A University of Chicago Medicine patient received the first dose of guselkumab (Tremfya) for ulcerative colitis, following FDA approval on Sept. 11. Tremfya, a monoclonal antibody targeting IL-23, was proven effective in a global study led by Dr. David T. Rubin, contributing to its approval for this use. Rubin, also the Director of UChicago Medicine’s Inflammatory Bowel Disease Center, highlighted the drug's safety and efficacy in clinical trials.
Johnson & Johnson's TREMFYA (guselkumab) approved by FDA for treating adults with moderately to severely active ulcerative colitis (UC). TREMFYA, a fully human monoclonal antibody, blocks IL-23 and binds to CD64, administered intravenously with a 200mg induction dose at weeks zero, four, and eight, followed by subcutaneous maintenance doses every eight or four weeks. The approval is based on the Phase II/III QUASAR study, showing 50% and 45% clinical remission rates at week 44 for 200mg and 100mg doses respectively, compared to 19% for placebo. TREMFYA now has three indications, including moderate-to-severe plaque psoriasis and active psoriatic arthritis.
The FDA approved guselkumab (Tremfya) for moderate-to-severe ulcerative colitis, showing 50% clinical remission at week 44 in the QUASAR study. Tremfya, a dual-acting IL-23 inhibitor, demonstrated significant symptom improvement and endoscopic normalization, with a safety profile consistent with previous findings.
The FDA approved Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis. It's the first dual-acting interleukin-23 inhibitor for this condition, administered as a 200 mg IV dose at weeks 0, 4, and 8. The approval is based on the QUASAR study, showing significant clinical and endoscopic remission rates compared to placebo.
FDA approves J&J's Tremfya for ulcerative colitis; Novo Nordisk's amycretin shows faster weight loss than Wegovy; Dupixent improves disease remission in bullous pemphigoid study.
TREMFYA®, the first dual-acting IL-23 inhibitor, received FDA approval for active ulcerative colitis, showing significant endoscopic remission rates in the QUASAR program. TREMFYA® is also approved for plaque psoriasis and psoriatic arthritis.
FDA approves Tremfya® (guselkumab) for moderately to severely active ulcerative colitis (UC) based on QUASAR study results. Guselkumab, an IL-23 antagonist, showed 23% clinical remission at week 12 vs. 8% with placebo. Maintenance trial revealed 45-50% clinical remission at week 44 with guselkumab vs. 19% with placebo. Common adverse reactions included respiratory tract infections and injection site reactions.
TREMFYA®, the first dual-acting IL-23 inhibitor, approved for active ulcerative colitis, showed significant endoscopic remission rates in the QUASAR program. Approved for plaque psoriasis, active psoriatic arthritis, and ulcerative colitis, TREMFYA® blocks IL-23 and binds to CD64, improving UC symptoms and intestinal lining appearance.
The FDA approved Johnson & Johnson’s Tremfya for treating adults with moderately to severely active ulcerative colitis, marking the first fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64. Tremfya showed significant clinical and endoscopic improvements, with 50% and 45% of patients achieving clinical remission at 200 mg and 100 mg doses, respectively, compared to 19% in the placebo group. Common adverse events included respiratory tract infections, injection site reactions, and arthralgia.
The FDA expanded guselkumab (Tremfya) indications for adults with moderately to severely active ulcerative colitis, based on QUASAR phase IIb/III findings showing higher rates of clinical and endoscopic remission. Guselkumab, an IL-23 inhibitor, also binds to CD64, entering a crowded field of ulcerative colitis treatments. Recommended dosing includes 200 mg IV at weeks 0, 4, and 8, with maintenance options of 100 mg every 8 weeks or 200 mg every 4 weeks. Adverse events include respiratory infections and injection site reactions. Guselkumab is also approved for plaque psoriasis and active psoriatic arthritis, with Crohn's disease evaluation ongoing.