Johnson & Johnson announced that the U.S. FDA has granted Fast Track designation to nipocalimab for the treatment of moderate-to-severe Sjögren's disease, following its previous Breakthrough Therapy designation. Sjögren's disease is a chronic autoimmune condition with no FDA-approved treatments targeting its underlying causes.

The company is actively enrolling patients in the Phase 3 DAFFODIL study to evaluate the therapy’s effectiveness. Earlier Phase 2 results from the DAHLIAS study showed significant improvement in disease activity and a reduction in IgG levels.

Nipocalimab is an investigational monoclonal antibody designed to block FcRn and lower autoantibody levels, potentially benefiting patients with autoimmune and maternal-fetal diseases. The FDA has previously granted the therapy multiple designations, including Fast Track, Orphan Drug, and Breakthrough Therapy status for other conditions.

Johnson & Johnson emphasized its commitment to advancing treatment options for Sjögren's disease and working closely with regulatory authorities. More information is available on the company’s website and through ongoing clinical trials.