FDA approves Omeros' YARTEMLEA as first therapy for TA-TMA; launch set for Jan 2026

OMEROS CORP

YARTEMLEA (narsoplimab-wuug) approved for adults and children ≥2 years with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
Pivotal trial CR rate 61%, EAP CR rate 68%; 100-day survival 73% and 74% respectively; all patients high-risk.
No Boxed Warning or REMS; most common adverse reactions (≥20%) include viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, hypokalemia.
U.S. launch planned for January 2026; dedicated ICD-10 and procedure codes in place; YARTEMLEAssist patient support program expected in Q1 2026.
Marketing authorization application under EMA review with decision expected mid-2026.

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