FDA批准Yartemlea为罕见、致命的移植条件, FDA approves Yartemlea for rare, deadly transplant condition, first targeting lectin pathway.

林业发展局批准了Yartemlea(narsoplimab-wouug)治疗与移植有关的血清微生物病(TA-TMA),这是干细胞移植后罕见的、往往是致命的疾病。 The FDA has approved Yartemlea (narsoplimab-wuug) for treating transplant-associated thrombotic microangiopathy (TA-TMA), a rare, often fatal condition after stem-cell transplants. 它是首个通过抑制MASP-2和保护其他免疫功能来向乳素通路的药物. It is the first drug approved to target the lectin pathway by inhibiting MASP-2, preserving other immune functions. 在临床和扩大的获取数据中,成人、儿童、2岁及2岁以上获得批准的人的完整回复率为61%至68%,临床和扩大的获取数据为73%至74%的100天存活率,一年存活率高达50%的易腐性病例。 Approved for adults and children two and older, it showed 61% to 68% complete response rates and 73% to 74% 100-day survival in clinical and expanded access data, with one-year survival up to 50% in refractory cases. 该药物定于2026年1月在美国发射,欧洲预计将于2026年年中作出决定。 The drug is set for U.S. launch in January 2026, with a European decision expected in mid-2026.