Johnson & Johnson (J&J) announced that the US Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjögren's disease (SjD). Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions, the company stated in a press release. Sjögren's disease (SjD) is a chronic autoimmune disease characterized by autoantibody production, chronic inflammation, including inflammation of tear-secreting glands that reduces tear production, and lymphocytic infiltration of exocrine glands. Dry eyes are one of the most comment symptoms of SjD.

J&J noted that no therapies are currently approved that treat the underlying and systemic nature of the disease.

Nipocalimab was granted Breakthrough Therapy designation (BTD) in late 2024. Results from the phase 2 DAHLIAS study, presented last year, represented the first positive results of an investigational FcRn blocker as a potential targeted therapy in SjD, J&J said in the press release. Nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa score vs placebo at 24 weeks compared to baseline (primary endpoint) in the phase 2 DAHLIAS dose-ranging study of nipocalimab in adult patients living with Sjögren’s disease (SjD). Response was demonstrated as early as Week 4 and continued to increase throughout the 24-week treatment period compared with patients receiving placebo.