FDA Approves Nipocalimab to Treat Sjögren’s Disease

Johnson & Johnson’s (J&J) anti-FcRn antibody nipocalimab is the first investigational therapy to be granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) as a treatment for adults with moderate-to-severe Sjögren’s disease (SjD). Nipocalimab is designed to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, potentially without impact on other immune functions.

Approval was based on positive results from the mid-stage DAHLIAS study evaluating its effects in more than 160 adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. Results demonstrated a statistically significant and clinically meaningful improvement in ClinESSDAI score, which measures disease activity across 11 organ systems, in nipocalimab-treated SjD patients versus placebo at 24 weeks compared to baseline.

According to Terence Rooney, vice president of rheumatology and immunology disease area leader at J&J Innovative Medicine, this “marks an important step forward in the continued research and development of nipocalimab, the first investigational FcRn blocker to demonstrate positive results in a Phase II study in adult patients with moderate-to-severe SjD. With no treatments currently approved that may directly address the underlying cause(s) of the disease, innovation is critically needed to improve patient outcomes in SjD.”

A Phase III trial of the candidate in SjD is currently underway.