EU panel upholds negative opinion on Omeros’ narsoplimab application
OMER•The EMA’s CHMP upheld its negative opinion on Omeros’ marketing application for narsoplimab after re-examining its June 2026 decision. The FDA approved the drug as Yartemlea in December 2025 for TA-TMA patients ages two and older.
1. European application review
The EMA’s CHMP upheld its negative opinion on Omeros’ application for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), following re-examination of its June 2026 decision. The article says there is no approved therapy for TA-TMA in Europe.
2. Access plans
Omeros plans fully reimbursed named-patient access where permitted in Europe rather than routine commercial access. The company also plans to end compassionate use as U.S. demand rises, while providing current patients enough drug to complete treatment.
