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
约翰逊和约翰逊（NYSE:JNJ）今天宣布向美国食品和药物管理局（FDA）提交了生物制品许可申请（BLA），以全球首次获得nipocalimab治疗全身性重症肌无力（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+
基于3期Vivacity-MG3计划的申请，这是类中首个且唯一证明具有持续24周抗体阳性成年患者疾病控制的研究结果：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 / - 约翰逊和约翰逊（NYSE:JNJ）今天宣布已向美国食品和药物管理局（FDA）提交了生物制品许可申请（BLA），以全球首次获得nipocalimab治疗全身性重症肌无力（gMG）患者的申请。