Marks first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies
Filing based on the Phase 3 Vivacity-MG3 program, the first-and-only study results in the class demonstrating sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+
SPRING HOUSE, Pa., Aug. 29, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the treatment of people living with generalized myasthenia gravis (gMG).