Yartemlea

Opinion under re-examinationHuman

Details

EMA number	EMEA/H/C/005247
ATC code	L01FX
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy 

MeSH: Thrombotic Microangiopathies;Hematopoietic Stem Cell Transplantation

Active substances

narsoplimab

Marketing Authorisation Holder

Omeros Ireland Limited

MAH

🇺🇸 Also approved in the US (FDA)

YARTEMLEA — OMEROS CORP, approved 2025-12-23 (BLA761152).

Most reported adverse events (US / FAERS)

23 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

thrombotic microangiopathy

3

disease recurrence

2

drug ineffective

2

gastrointestinal haemorrhage

2

🇺🇸 Also approved in the US (FDA)

YARTEMLEA — OMEROS CORP, approved 2025-12-23 (BLA761152).

Most reported adverse events (US / FAERS)

23 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

thrombotic microangiopathy

3

disease recurrence

2

drug ineffective

2

gastrointestinal haemorrhage

2

hypertension

2

respiratory failure

2

thrombocytopenia

2

acute kidney injury

1

acute respiratory distress syndrome

1

acute respiratory failure

1

allogenic stem cell transplantation

1

blood creatinine increased

1

bone marrow failure

1

candida infection

1

cardiac arrest

1