EMA Upholds Negative Opinion on Omeros’ Narsoplimab Application
The EMA committee upheld its negative opinion on Omeros’ marketing authorization application for narsoplimab, a treatment for transplant-associated thrombotic microangiopathy.
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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.
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