Omeros faces negative EMA panel opinion on narsoplimab marketing application for TA-TMA

Omeros Corporation

Omeros Corporation

OMER

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  • Omeros faces a setback in Europe after the EMA’s CHMP adopted a negative opinion on its marketing application for TA-TMA drug narsoplimab.
  • The company plans to seek a CHMP re-examination, including review by an EMA-convened Ad Hoc Expert Group.
  • Narsoplimab, sold as YARTEMLEA, won FDA clearance in December 2025, leaving Europe without an authorized TA-TMA treatment.
  • Omeros plans to keep supplying YARTEMLEA in Europe via compassionate use, though access will remain limited without EMA authorization.


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