JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease

Core Insights - Johnson & Johnson (JNJ) has received Fast Track designation from the FDA for its investigational drug nipocalimab, aimed at treating moderate-to-severe Sjögren's disease (SjD), a chronic autoimmune condition [1][2] - Nipocalimab has also been granted Fast Track designation for three additional indications: hemolytic disease of the fetus and newborn (HDFN), warm autoimmune hemolytic anemia (wAIHA), and generalized myasthenia gravis (gMG) [3] - The FDA previously granted Breakthrough Therapy designation for nipocalimab in SjD in November 2024, with positive phase II study results announced in February 2025 [4] Drug Development and Regulatory Status - A biologics license application (BLA) for nipocalimab in treating gMG is currently under review, with priority review status granted by the FDA [6][8] - The BLA is supported by data from the phase III Vivacity-MG3 study, with a final decision expected in the third quarter of 2025 [8] - JNJ is also advancing nipocalimab in late-stage studies for chronic inflammatory demyelinating polyneuropathy, HDFN, and wAIHA, as well as mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus [9] Financial Performance - Over the past year, JNJ's shares have increased by 5.4%, contrasting with a 4.3% decline in the industry [5]