Category: Autoimmune Diseases

Regulatory Approval Autoimmune Diseases News Regulatory

U.S. FDA Approves Lilly’s Omvoh (mirikizumab-mrkz) as a Single-Injection Monthly Maintenance Dose for Ulcerative Colitis

Eli Lilly and Company

Eli Lilly has received FDA approval for a new single-injection maintenance dose of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis. This approval simplifies the treatment regimen from two monthly injections down to just one, offering the same proven efficacy in a more convenient format. The new 200 mg/2 mL prefilled pens and syringes are expected to be available in the U.S. in early 2026.

Clinical Trials Autoimmune Diseases News

TREMFYA® (guselkumab) Demonstrates Durable Two-Year Remission in Crohn’s Disease, New Phase 3 Data Show

JohnsonAndJohnson

New 96-week data from the Phase 3 GALAXI and GRAVITI studies show high rates of sustained remission for TREMFYA® (guselkumab) in Crohn’s disease. At two years, over 86% of patients on maintenance doses achieved clinical remission, reinforcing its long-term efficacy as the only fully subcutaneous IL-23 inhibitor for the condition.

Regulatory Approval Autoimmune Diseases News

Roche’s Gazyva/Gazyvaro Gets U.S. FDA Approval for Lupus Nephritis Treatment

Roche

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis. Based on positive results from Phase II and III clinical trials, this new therapy offers a significant advancement for those suffering from this severe kidney complication of lupus, showing superiority over standard therapy alone.

Regulatory Approval Autoimmune Diseases News

U.S. FDA Approves Johnson & Johnson’s SIMPONI® (golimumab) for Pediatric Ulcerative Colitis

JohnsonAndJohnson

Johnson & Johnson announces that the U.S. FDA has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis in children weighing at least 15 kg. This approval provides a new subcutaneous treatment option for younger UC patients.

Clinical Trials Autoimmune Diseases News

Lilly’s Omvoh Shows Sustained, Long-Term Efficacy in Ulcerative Colitis and Crohn’s Disease

Eli Lilly and Company

Eli Lilly and Company announced a significant milestone for Omvoh (mirikizumab-mrkz), which is now the first and only IL-23p19 antagonist to demonstrate four years of sustained, corticosteroid-free comprehensive patient outcomes for individuals living with ulcerative colitis (UC).

Regulatory Approval Autoimmune Diseases News

FDA Approves First-of-its-Kind Psoriasis and Arthritis Treatment for Children

JohnsonAndJohnson

The U.S. Food and Drug Administration (FDA) has given approval to TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in children. This groundbreaking approval makes TREMFYA® the first and only IL-23 inhibitor available for pediatric patients, offering a new ray of hope for thousands of children affected by these chronic conditions.

Clinical Trials Autoimmune Diseases Healthcare & Pharmaceuticals News

Roche Highlights New OCREVUS® Data Demonstrating Benefit in Diverse MS Populations and Presents Promising Long-Term Fenebrutinib Results at ECTRIMS 2025

Roche

Roche is set to present a wealth of new data at the 41st ECTRIMS Congress, highlighting the expanding benefits of its flagship multiple sclerosis therapy, OCREVUS® (ocrelizumab). New findings demonstrate a significant reduction in disability progression for adults with advanced primary progressive MS (PPMS) and reinforce its safety for pregnant women and their infants. The presentation will also include the first comparative data for OCREVUS in pediatric MS. Alongside these updates, Roche will showcase promising two-year results for its investigational oral BTK inhibitor, fenebrutinib, which showed near-complete suppression of disease activity in patients with relapsing MS ahead of pivotal Phase III readouts.

Biologics Autoimmune Diseases Healthcare & Pharmaceuticals News Regulatory Approval

U.S. FDA Approves Johnson & Johnson’s TREMFYA® (guselkumab) Subcutaneous Induction for Adults with Ulcerative Colitis

JohnsonAndJohnson

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new subcutaneous (at-home) induction option for TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis. This approval, based on the successful Phase 3 ASTRO trial, makes TREMFYA the first and only IL-23 inhibitor to offer a completely subcutaneous regimen for both induction and maintenance, providing a significant new convenience for patients managing their condition.