Thursday, Johnson & Johnson (NYSE:JNJ) announced the submission of a Biologics License Application (BLA) to the FDA seeking the first approval of nipocalimab globally for generalized myasthenia gravis (gMG).
gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
The update marks the first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce autoantibody levels.
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The application included data from the Phase 3 Vivacity-MG3 study, which showed that outcomes for a broad population of antibody-positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC.
In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving a statistically significant reduction in MG-ADL score from baseline over weeks 22 to 24 compared with placebo.
Earlier this year, at the American Academy of Neurology Annual Meeting, Johnson & Johnson presented data on the molecular properties of nipocalimab.
Last year, the FDA approved UCB SA's (OTC:UCBJF) (OTC:UCBJY)
Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
The company says Rystiggo is the only FDA-approved treatment in adults for anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
Johnson & Johnson's drug will also compete with Argenx SE's (NASDAQ:ARGX) Vyvgart Hytrulo for gMG in adult patients who are anti-acetylcholine receptor antibody positive.
The drug is available in subcutaneous and intravenous injections.
Price Action: JNJ stock is up 0.36% at $164.51 at the last check on Thursday.
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周四，强生公司（纽约证券交易所代码：JNJ）宣布向美国食品药品管理局提交生物制剂许可申请（BLA），寻求在全球范围内首次批准尼波卡利单抗治疗全身性重症肌无力（GmG）。
GmG 是一种自身抗体驱动的神经肌肉疾病，其特征是肌肉无力波动。
该更新标志着美国食品药品管理局首次提交nipocalimab，这是一种具有高亲和力和特异性结合的在研药物，可阻断fcRN并降低自身抗体水平。
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该申请包括来自3期Vivacity-MG3研究的数据，该研究表明，与接受安慰剂加SOC的受试者相比，接受nipocalimab加标准护理（SOC）的广大抗体阳性参与者的预后更好。
在GmG的3期VIVACITY研究中，尼泊卡利单抗达到了主要终点，与安慰剂相比，在第22周至第24周内，MG-ADL评分从基线开始显著降低。
今年早些时候，在美国神经病学会年会上，强生公司提供了有关尼泊卡利单抗分子特性的数据。
去年，美国食品药品管理局批准了uCb SA（场外交易代码：UCBJF）（场外交易代码：UCBJY）
Rystiggo（rozanolixumab-noli）用于治疗抗乙酰胆碱受体（AchR）或抗肌肉特异性酪氨酸激酶（mUSK）抗体阳性的成年患者的全身性重症肌无力（gMG）。
该公司表示，Rystiggo是唯一获得美国食品药品管理局批准的成人抗ACHR和抗麝香抗体阳性gmG的治疗方法，这两种最常见的gmG亚型。
强生公司的药物还将与Argenx SE（纳斯达克股票代码：ARGX）的Vyvgart Hytrulo竞争，在抗乙酰胆碱受体抗体阳性的成人患者中获得转基因组蛋白。
该药物有皮下和静脉注射两种形式。
价格走势：在周四的最后一次支票中，JNJ股价上涨0.36％，至164.51美元。
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图片由 Sundry 摄影通过 Shutterstock 拍摄
