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News 2026-10-16 10:55 UTC

EU Panel Upholds Negative Opinion on Omeros Narsoplimab Application

The European Medicines Agency’s CHMP upheld its negative opinion on Omeros’ narsoplimab application for TA-TMA after re-examination. Omeros also plans to end its compassionate-use program, while current patients will receive enough drug to complete treatment.

News 2026-10-16 10:22 UTC

EU Panel Upholds Negative Opinion on Omeros’ Narsoplimab Application

EMA's CHMP upheld its negative opinion on Omeros' narsoplimab marketing application following re-examination of its June 2026 decision. The application covers hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), which has no approved therapy in Europe. The FDA approved narsoplimab as Yarte