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Single Patient Expanded Access Treatment Plan (EAP; Also Known As A Compassionate Use Plan) To Provide Patients Access To The Investigational Product Narsoplimab

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Trial Profile

Single Patient Expanded Access Treatment Plan (EAP; Also Known As A Compassionate Use Plan) To Provide Patients Access To The Investigational Product Narsoplimab

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 10 Mar 2026

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At a glance

  • Drugs Narsoplimab (Primary)
  • Indications Haemolytic anaemia; Thrombocytopenia; Thrombotic microangiopathy
  • Focus Expanded access; Registrational; Therapeutic Use
  • Sponsors Omeros Corporation

Most Recent Events

  • 05 Mar 2026 Status changed from recruiting to completed.
  • 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.

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