EMA Rejects Omeros’ Narsoplimab Appeal

Omeros leadership expressed sharp frustration regarding the re-examination process, alleging that critical patient-level data submitted in August was never shared with the expert group tasked with reviewing the application. Chief Executive Gregory Demopulos characterized the outcome as deeply disappointing, citing a procedural failure in how the committee handled the additional evidence provided by the firm.

While the drug remains barred from the European Union, it is already authorized in the United States under the brand name Yartemlea. Omeros currently maintains commercial control in the U.S. and maintains that it will seek a third-party licensing partner to manage European distribution should the regulatory situation shift. The treatment targets hematopoietic stem cell transplant-associated thrombotic microangiopathy, a condition known for high mortality rates in both pediatric and adult transplant patients.