Omeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA
Key Highlights
- ➤CHMP issued a negative opinion on narsoplimab’s European marketing application after re-examination
- ➤YARTEMLEA remains FDA-approved for TA-TMA patients aged two and older
- ➤Omeros plans to terminate compassionate use as U.S. commercial demand increases
- ➤Omeros plans ARDS and pediatric TA-TMA prevention studies later this year
Expert Statements
Gregory A. Demopulos, Chairman and Chief Executive Officer of Omeros
“We are deeply disappointed in the re-examination process and outcome”
Gregory A. Demopulos, Chairman and Chief Executive Officer of Omeros
“We believe that our YARTEMLEA efficacy and safety data, FDA’s recent approval with a broad indication for both adults and children, a decade of compassionate use requests by European transplant physicians for their TA-TMA patients, and the rapid U.S. commercial adoption speak clearly to the favorable benefit-risk profile of the drug.”
Gregory A. Demopulos, Chairman and Chief Executive Officer of Omeros
“As YARTEMLEA continues to progress toward becoming the standard of care in the U.S., it is disheartening that patients in Europe will not have routine access to its potentially life-saving benefits.”
Gregory A. Demopulos, Chairman and Chief Executive Officer of Omeros
“As we advance our efforts to expand YARTEMLEA’s use and indications worldwide and to develop our MASP-2 franchise further, we are working to enable fully reimbursed, named-patient access to YARTEMLEA for those with TA-TMA where permitted in Europe and other regions.”
Omeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA
Omeros Corporation (Nasdaq: OMER) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the company’s marketing authorization application (MAA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) following re-examination of its original negative opinion adopted in June 2026.
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