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An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

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Trial Profile

An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs Fitusiran (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Adverse reactions; Registrational
  • Acronyms ATLAS-OLE
  • Sponsors Sanofi Genzyme

Most Recent Events

  • 28 Mar 2025 According to Sanofi Media Release, the US FDA approved Qfitlia (fitusiran), as the first therapy in the US to treat hemophilia A or B with or without inhibitors based on the data from this trail along with other ATLAS trials.
  • 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.
  • 21 Jun 2024 According to Sanofi media release, company will present new data from its hemophilia portfolio at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH), taking place June 22-26, 2024, in Bangkok, Thailand.

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