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Reported Friday, Johnson & Johnson Reports Nipocalimab Achieved Statistically Significant Reduction In ClinESSDAI Scores At Week 24 With Strong Efficacy And Tolerability In Sjögren's Disease

Author: Benzinga Newsdesk | October 27, 2025 02:19am

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

Posted In: JNJ