J&J releases positive Phase III for gMG and SjD candidate nipocalimab
US healthcare giant Johnson & Johnson (NYSE: JNJ) late Monday announced top-line results from the pivotal Phase III VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG), as well as the Phase II DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD).
Nipocalimab, which J&J acquired in its $6.5 billion buy of Momenta Pharmaceuticals in 2020, has demonstrated clinical effect in four autoantibody-driven diseases within the past year, including hemolytic disease of the fetus and newborn (HDFN) and rheumatoid arthritis, in addition to gMG and SjD.
In the Phase III VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving statistically significant reduction in MG-ADLa score from baseline over weeks 22 to 24 compared with placebo (PBO). gMG is a chronic, life-long, rare, and highly debilitating autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
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