Johnson & Johnson Seeks First Approval Of Nipocalimab To Treat Broadest Population Living With Antibody Positive Generalized Myasthenia Gravis
Johnson & Johnson Seeks First Approval Of Nipocalimab To Treat Broadest Population Living With Antibody Positive Generalized Myasthenia Gravis
Marks first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies
約翰遜和約翰遜（NYSE:JNJ）今天宣佈向美國食品和藥物管理局（FDA）提交了生物製品許可申請（BLA），以全球首次獲得nipocalimab治療全身性重症肌無力（gMG）患者的批准。
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+
基於3期Vivacity-MG3計劃的申請，這是類中首個且唯一證明具有持續24周抗體陽性成年患者疾病控制的研究結果：抗-AChR+，抗-MuSK+，抗-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).
PA州斯普林豪斯，2024年8月29日 / PRNewswire / - 約翰遜和約翰遜（NYSE:JNJ）今天宣佈已向美國食品和藥物管理局（FDA）提交了生物製品許可申請（BLA），以全球首次獲得nipocalimab治療全身性重症肌無力（gMG）患者的申請。
