FDA Approves Rystiggo: The Only Treatment for Two Most Common Subtypes of Generalized Myasthenia Gravis in Adults
FDA Approves Rystiggo: The Only Treatment for Two Most Common Subtypes of Generalized Myasthenia Gravis in Adults
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.
美国食品药品管理局批准了 UCB SA's (OTC: UCBJF) (OTC: UCBJY) Rystiggo (rozanolixizumab-noli) 用于抗乙酰胆碱受体 (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)。
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.
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。
The FDA approval is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study. The primary efficacy endpoint was comparing the change from baseline between treatment groups in the MG-ADL total score, a measurement tool that assesses the impact of gMG on the daily functions of 8 signs or symptoms.
美国食品药品管理局的批准得到了关键的3期MyCaring研究的安全性和有效性数据的支持。主要疗效终点是在MG-ADL总分中比较治疗组与基线的变化，MG-ADL总分是一种评估gmG对8种体征或症状日常功能影响的测量工具。
A statistically significant difference favoring Rystiggo was observed in the MG-ADL total score change from baseline [-3.4 points in the Rystiggo-treated group at either dose vs. -0.8 points in the placebo-treated group.
在接受Rystiggo治疗的组中，MG-ADL总分与基线相比存在统计学上的显著差异 [在任何剂量下均为-3.4分，而安慰剂治疗组的MG-ADL总分变化为-0.8分。
Rystiggo will be commercially available in the U.S. during Q3 of 2023.
Rystiggo将于2023年第三季度在美国上市。
Last week, the FDA approved Argenx SE's (NASDAQ: ARGX) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), an injection for subcutaneous (SC) use for gMG in adult patients who are anti-acetylcholine receptor antibody positive. These patients represent approximately 85% of the total gMG population.
上周，美国食品药品管理局批准了 Argenx SE's （纳斯达克股票代码：ARGX）Vyvgart Hytrulo（efgartigimod alfa 和透明质酸酶-qvfc），一种用于抗乙酰胆碱受体抗体阳性的成人患者的皮下（SC）注射剂。这些患者约占总GmG人群的85％。
译文内容由第三方软件翻译。