Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation

Company Overview - Johnson & Johnson announced that the FDA granted Fast Track designation for nipocalimab, an investigational therapy for moderate-to-severe Sjögren's disease, marking the fourth such designation for this drug [1][2] - Nipocalimab is the first and only therapeutic to receive Breakthrough Therapy designation for SjD, aimed at accelerating the development and review of drugs for serious conditions [2] Clinical Development - The company is actively enrolling patients in the Phase 3 DAFFODIL study, which follows the positive results from the Phase 2 DAHLIAS study that demonstrated a greater than 70% relative average improvement in systemic disease activity at Week 24 for the 15 mg/kg nipocalimab group [1][4] - The DAHLIAS study involved 163 adults with primary Sjögren's disease and assessed the effects of nipocalimab compared to placebo [6] Disease Context - Sjögren's disease is a prevalent autoimmune condition affecting approximately four million people globally, with a higher incidence in women [5] - The disease is characterized by chronic inflammation and can lead to severe complications, including a 20 times greater risk of developing B-cell lymphomas compared to the general population [4][5] Treatment Landscape - Currently, there are no FDA-approved treatments that address the underlying causes of Sjögren's disease, highlighting the unmet medical need for effective therapies [4][5] - Nipocalimab is designed to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, potentially offering a new treatment option for patients [8]