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ATLAS-PPX: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in patients with hemophilia A and B previously receiving factor or bypassing agent prophylaxis

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Trial Profile

ATLAS-PPX: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in patients with hemophilia A and B previously receiving factor or bypassing agent prophylaxis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Aug 2024

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At a glance

  • Drugs Fitusiran (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-PPX
  • Sponsors Alnylam Pharmaceuticals; Sanofi Genzyme; Sanofi K.K.

    • Most Recent Events

    • 21 Jun 2024 According to Sanofi Media Release, the regulatory submissions for fitusiran for the treatment of hemophilia A or B in adults and adolescents with or without inhibitors have been completed in China, Brazil and the US with a US Food and Drug Administration (FDA) target action date of March 28, 2025. Regulatory decision in China expected in H2 2025.
    • 12 Dec 2023 Results of pooled analysis from Phase 1 (NCT02035605), Phase 1/2 (NCT02554773) and Phase 3 studies (NCT03417102, NCT03417245, NCT03549871) in PwH A/B, with or without inhibitors, PopPK/PD model, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 22 Sep 2023 This trial has been discontinued in Spain (Date of the global end of the trial: 25-Mar-2022), according to the European Clinical Trials Database record.

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