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A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

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Trial Profile

A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2024

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At a glance

  • Drugs Eculizumab (Primary) ; Eculizumab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis

    • Most Recent Events

    • 22 Jul 2024 According to a Samsung Bioepis media release, based on data form NCT03722329 and NCT04058158, the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for EPYSQLI (eculizumab-aagh) as a biosimilar to Soliris1 (eculizumab). EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
    • 30 May 2024 According to a Samsung Bioepis media release, data from post hoc analysis of this trial will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress
    • 12 Dec 2023 Results of subgroup analysis assessing the efficacy of SB12 in Asian and non-Asian patients, presented at the 65th American Society of Hematology Annual Meeting and Exposition

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