Johnson & Johnson

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 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.

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.

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.

Janssen-Cilag International NV, a Johnson & Johnson company, submitted a Marketing Authorisation Application to the European Medicines Agency for nipocalimab, seeking its first approval for treating generalised myasthenia gravis, based on Phase 3 Vivacity-MG3 study data.

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.

Janssen-Cilag International NV submitted an MAA to the EMA for nipocalimab, seeking approval for treating generalized myasthenia gravis (gMG). Bill Martin, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, expressed optimism about nipocalimab's potential to control gMG, highlighting the company's commitment to innovative treatments for autoantibody-driven diseases.

Janssen-Cilag International NV submits MAA to EMA for nipocalimab, an FcRn blocker, based on Phase 3 Vivacity-MG3 study showing sustained disease control in antibody-positive gMG patients over 24 weeks.

Janssen-Cilag submits MAA to EMA for nipocalimab, an FcRn blocker for gMG, based on Phase 3 Vivacity-MG3 study results showing sustained disease control in antibody-positive patients over 24 weeks.

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.