Trial Profile
A Compassionate Use study of Narsoplimab in Nine Patients with Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy
Status:
Completed
Phase of Trial:
Clinical Phase Unknown
Latest Information Update: 17 Jul 2025
Price :
$35
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At a glance
- Drugs Narsoplimab (Primary)
- Indications Thrombotic microangiopathy
- Focus Adverse reactions; Expanded access; Registrational; Therapeutic Use
- Sponsors Omeros Corporation
Most Recent Events
- 27 Jun 2025 According to an Omeros Corporation media release, the review of MAA will begin in mid-July and the CHMP will issue an opinion after their scientific assessment. The final decision about the adoption of CHMP opinion by the European Commission, is expected in mid-2026.
- 27 Jun 2025 According to an Omeros Corporation media release, the company has submitted the MAA to EMA for narsoplimab for the treatment of TA-TMA. It also includes outcomes in over 130 TA-TMA patients under Omeros' expanded access program. The orphan drug designation granted by EMA review of the MAA through the centralized procedure covering all EU member states and the EEA countries of Iceland, Liechtenstein and Norway.
- 06 May 2025 According to an Omeros Corporation media release, the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The resubmission was classified as a Class 2 resubmission and pursuant to the Prescription Drug User Fee Act (PDUFA) has been assigned a target action date for the FDA decision in late September 2025.