Nipocalimab, an investigational monoclonal antibody from Johnson & Johnson, has received the U.S. Food and Drug Administration’s Fast Track Designation for the treatment of moderate-to-severe Sjögren’s syndrome in adult patients, according to a Johnson & Johnson press release.

The Phase 2 DAHLIAS study, released in 2024, revealed that the 15 mg/kg Q2W nipocalimab group showed a greater than 70% relative average improvement in systemic disease activity at Week 24 vs. those in the placebo group.

Additionally, the nipocalimab group showed IgG reductions of more than 77%, according to the press release.

This study was comprised of 163 adults ages 18 to 75 who were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg or placebo every 2 weeks through Week 22.

Johnson & Johnson is now actively enrolling patients in the Phase 3 DAFFODIL  study. OM