# 美國食品藥物管理局批准 Vyvgart 標籤擴展。

*biotech · news · 2026-05-08 · MarketScreener*

## Key points

- FDA 批准 Argenx 的 Vyvgart 及 Vyvgart Hytrulo 治療標籤擴展。
- Vyvgart 現已適用於所有血清型的成人廣泛性重症肌無力患者。
- 擴大批准基於 Argenx 第三期臨床研究數據。
- 研究中接受 Vyvgart 治療的患者顯示出快速且持續的症狀改善。

By Christopher Kuo Argenx SE said the Food and Drug Administration approved a label expansion for Vyvgart and Vyvgart Hytrulo, the company's treatments for a rare, chronic autoimmune disorder known as generalized myasthenia gravis. The approved supplemental Biologics License Application expands Vyvgart's indication to include all serotypes of adult patients living with generalized myasthenia gravis, a disease that can result in debilitating and life-threatening muscle weakness, the company said Friday. The approval is based on data from the company's Phase 3 study, in which patients treated with Vyvgart showed rapid and sustained improvements in their disease symptoms, the company said. Write to Christopher Kuo at chris.kuo@wsj.com (END) Dow Jones Newswires 05-08-26 1755ET

**Companies:** Argenx SE

[Read the full story on MarketScreener](https://www.marketscreener.com/news/fda-approves-label-expansion-for-argenx-treatment-of-autoimmune-disease-ce7f5bdbd18cf225)

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