Johnson & Johnson Unveils First and Only Nipocalimab for the Treatment of Sjögren’s disease
Johnson & Johnson has introduced nipocalimab as the first investigational therapy for adults with moderate-to-severe Sjögren’s disease (SjD), a chronic autoimmune condition affecting approximately four million people globally, predominantly women. Currently, no advanced treatments are approved for this debilitating disease.
Nipocalimab, a monoclonal antibody designed to bind with high affinity and block the neonatal Fc receptor (FcRn), helps reduce levels of circulating immunoglobulin G (IgG) antibodies, potentially without affecting other immune functions.
This includes reducing autoantibodies and alloantibodies, which are involved in conditions across three main areas: rare autoantibody diseases, maternal-foetal diseases mediated by maternal alloantibodies, and prevalent rheumatological conditions.
Additionally, blocking IgG binding to FcRn in the placenta may prevent the transplacental transfer of maternal alloantibodies to the foetus.
Sjögren’s disease (SjD) is marked by the production of autoantibodies, chronic inflammation, and lymphocytic infiltration of exocrine glands, leading to symptoms such as mucosal dryness, joint pain, and fatigue.
The DAHLIAS Phase 2 study is a multicenter, randomised, placebo-controlled, double-blind trial assessing the impact of nipocalimab on adults with moderately-to-severely active primary SjD who are seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies.
Nipocalimab is the first and only investigational treatment to receive U.S. FDA breakthrough therapy designation for adults with moderate-to-severe Sjögren’s disease.
