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Omeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA

OMER
  • The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on Omeros Corporation's marketing authorization application for narsoplimab (YARTEMLEA) to treat TA-TMA following a re-examination of its original June 2026 decision.
  • An eight-member ad hoc expert group (AHEG) convened by CHMP recommended that external experts review individual patient-level data to better understand treatment response factors, though CHMP did not provide this data to the group.
  • YARTEMLEA received FDA approval in December 2025 as the first and only therapy for TA-TMA in patients aged two years and older, with no currently approved therapies for this condition in Europe.
  • Omeros is commercializing YARTEMLEA directly in the U.S. market but planned to license rights to a third party in the EU had authorization been granted.
  • CEO Gregory A. Demopulos expressed deep disappointment in the outcome, citing the drug's favorable benefit-risk profile, FDA approval, & prior compassionate use requests by European physicians as evidence of its value.
  • Due to increasing U.S. demand, Omeros informed CHMP of its intention to terminate the YARTEMLEA compassionate-use program while ensuring current patients receive sufficient drug to complete treatment.
  • The company is pursuing additional indications for its MASP-2 franchise, including clinical studies for acute respiratory distress syndrome (ARDS) and high-risk TA-TMA prevention in pediatric patients later this year.
  • YARTEMLEA targets MASP-2 to inhibit the lectin pathway of complement, distinguishing itself by lacking a boxed warning, REMS, or vaccination requirement.
  • Clinical trials reported serious infections in 36% of patients treated with YARTEMLEA, with common adverse reactions including viral infections, sepsis, hemorrhage, & diarrhea.
  • Omeros continues to develop its pipeline, including the long-acting antibody OMS1029, the oral small-molecule inhibitor OMS527 for cocaine use disorder, & assets previously acquired by Novo Nordisk.