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ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX

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Trial Profile

ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Aug 2024

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At a glance

  • Drugs Fitusiran (Primary) ; Factor IX; Factor VIII
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-A/B
  • 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
    • 04 Apr 2023 According to Sanofi Media Release, the company look forward to sharing additional data on fitusiran later this year.

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