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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).
Posted In: JNJ
