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.
美國食品藥品管理局批准了 UCB SA's (OTC: UCBJF) (OTC: UCBJY) Rystiggo (rozanolixizumab-noli) 用於抗乙酰膽鹼受體 (achR) 或抗肌肉特異性酪氨酸激酶 (musK) 抗體陽性的成年患者的全身性重症肌無力 (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.
該公司表示，Rystiggo是唯一獲得美國食品藥品管理局批准的成人抗ACHR和抗麝香抗體陽性gmG的治療方法，這兩種最常見的gmG亞型。
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.
美國食品藥品管理局的批准得到了關鍵的3期MyCaring研究的安全性和有效性數據的支持。主要療效終點是在MG-ADL總分中比較治療組與基線的變化，MG-ADL總分是一種評估gmG對8種體徵或症狀日常功能影響的測量工具。
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治療的組中，MG-ADL總分與基線相比存在統計學上的顯著差異 [在任何劑量下均爲-3.4分，而安慰劑治療組的MG-ADL總分變化爲-0.8分。
Rystiggo will be commercially available in the U.S. during Q3 of 2023.
Rystiggo將於2023年第三季度在美國上市。
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.
上週，美國食品藥品管理局批准了 Argenx SE's （納斯達克股票代碼：ARGX）Vyvgart Hytrulo（efgartigimod alfa 和透明質酸酶-qvfc），一種用於抗乙酰膽鹼受體抗體陽性的成人患者的皮下（SC）注射劑。這些患者約佔總GmG人羣的85％。
譯文內容由第三人軟體翻譯。