智通财经APP获悉，强生(JNJ.US)宣布，美国FDA已批准其抗体疗法Imaavy(nipocalimab)上市，用于治疗抗AChR、抗MuSK抗体阳性的全身性重症肌无力(gMG)成人与12岁以上儿童患者。根据新闻稿，该疗法是获批用于治疗该类患者群体的首款新生儿Fc受体(FcRn)阻断剂。
此外，根据此前的新闻稿，该疗法也是在抗体阳性gMG患者中，与标准治疗(SOC)联合使用时，在改善患者日常生活活动(MG-ADL)评分方面上显著优于安慰剂的首个FcRn阻断剂。由于nipocalimab具有治疗多种自身免疫疾病的潜力，这款疗法在年初被行业媒体Evaluate列为今年有望上市的10大潜在重磅疗法之一。
此前公布的3期研究数据显示，从基线开始，nipocalimab可使总IgG的中位水平降低最多达75%。此外，研究还观察到常见的致病性IgG(如抗AChR抗体和抗MuSK抗体)水平在24周内显著下降。研究未观察到总IgE、IgA和IgM的变化，这表明即使在致病性IgG自身抗体水平下降后，保护性免疫系统仍可能保持正常功能。
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