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Aggregate AI 摘要 STAT News 生物医药 28 Aug 2026 - 04:01

STAT+: FDA approves Roivant therapy for rare autoimmune disease

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关键摘要

FDA批准Roivant旗下Lisraya治疗罕见皮肌炎,患者约4万至7万人

  • Lisraya(brepocitinib)为口服日服一次新药
  • 用于治疗伴肌肉无力与皮疹的罕见自身免疫病皮肌炎
  • 当前标准疗法为高剂量激素及其他免疫抑制剂

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正文提要

The Food and Drug Administration on Thursday approved a new medicine from Roivant and its subsidiary Priovant for the treatment of dermatomyositis, a rare autoimmune disease characterized by muscle weakness and a painful skin rash. 

The drug, called brepocitinib, will be marketed under the brand name Lisraya. It’s a pill taken once daily. 

High doses of steroids and other immune-suppressing drugs are the current standard of care for patients with dermatomyositis, which affects between 40,000 and 70,000 people in the U.S., according to Roivant. 

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