Omeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA
The CHMP issued a negative opinion on Omeros' EU marketing authorization application for narsoplimab in TA-TMA, upholding its June 2026 rejection after re-examination. The expert panel was not given patient-level data Omeros had submitted, and recommended further external review of individual patient-level data — leaving no clear EU approval path. The U.S. franchise is unaffected: YARTEMLEA was FDA-approved in December 2025 with a broad indication and no boxed warning, and is commercialized by Omeros' own U.S.
Key figures
- Drug Name
- narsoplimab (YARTEMLEA)
- Us status
- FDA-approved December 2025 for TA-TMA ages 2+, marketed as YARTEMLEA
- Eu outcome
- CHMP negative opinion following re-examination (June 2026 original negative opinion upheld)
AI analysis
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