Press releases

First-line treatment with TREMFYA® shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile More than half of TREMFYA®-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study

Nipocalimab, a first-in-class FcRn blocker being investigated for SjD, met its primary endpoint in the Phase 2 DAHLIAS study with statistically significant improvement in ClinESSDAI score, which is based on 11 key systemic disease domains, at Week 24 versus placebo Critical patient-reported SjD symptoms including dryness, pain and fatigue trended towards greater improvement in the nipocalimab-treated group compared to placebo-treated patients Nipocalimab is the only investigational treatment to be granted Breakthrough Therapy Designation (BTD) by U.S. FDA for the treatment of adults living with moderate-to-severe SjD, and the Phase 3 DAFFODIL study is currently enrolling patients

TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA® achieved high levels of skin clearance vs. placebo at Week 16

TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis

Sjögren’s disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments The Company is actively enrolling patients in the Phase 3 DAFFODIL study This marks the fourth nipocalimab FDA Fast Track designation

Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis