Yartemlea (Narsoplimab)

Where it stands

In the EU, Yartemlea (narsoplimab), from Omeros Ireland Limited, received a CHMP negative opinion on 2026-10-15. The record shows no approval date, so there is no EU marketing authorisation. The indication under review was treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

In the US the picture is different. The FDA approved Yartemlea (narsoplimab-wuug) on 2025-12-23 under BLA761152, recorded as a new biologic with priority review, supplied as an injection. The US sponsor is listed as Omeros Corp. The same substance is therefore approved in the US and has a negative opinion in the EU.

The records do not say what grounds the CHMP gave for its negative opinion, and they do not give the FDA-approved indication wording. The two indications therefore cannot be compared from this data.

Regulatory pathway and designations

The EU record shows no designations. That means none is recorded here, not that none exists. This analysis does not assume or infer any orphan, PRIME or similar status for the EU.

The US record notes priority review. This is an FDA review-speed designation for applications that could offer a significant improvement in treating a serious condition, and it carries a shorter review goal than standard review. It is not an EU designation and has no bearing on the CHMP outcome. The FDA approval is listed as a new biologic under a BLA.

In general EU procedure, a CHMP opinion is not itself a marketing authorisation. The European Commission issues the legally binding decision, and after a negative opinion that decision normally refuses the authorisation. The records show no Commission decision for this product.

Safety and pharmacovigilance

The records contain no safety data, risk management information or pharmacovigilance commitments for Yartemlea, so no safety assessment can be made from them.

What to watch

The main question is whether Omeros Ireland Limited seeks re-examination. Under EU procedure the applicant can notify the EMA of its intention to request re-examination within 15 days of receiving the opinion, and must submit detailed grounds within 60 days of receipt. The CHMP then re-examines the opinion, normally within 60 days of receiving those grounds. The records do not show whether this has been requested.

If no re-examination is requested, or the negative opinion is confirmed, expect a Commission decision refusing authorisation. The EMA would then normally publish its assessment documentation. That documentation would show the CHMP's reasoning, which the records here do not contain.

Also watch for anything that changes the US picture. The US approval is recorded, but the records give no information on post-marketing requirements, labelling details or other regional filings. Any move by the sponsor to reconcile the EU and US positions would be a regulatory signal, but the records give no indication of one.