Trial Profile
ATLAS-INH: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, with inhibitory antibodies to factor VIII or IX
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 01 Apr 2025
Price :
$35
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At a glance
- Drugs Fitusiran (Primary) ; Factor IX inhibitors; Factor VIII inhibitor bypassing fraction; Recombinant factor VIIa
- Indications Haemophilia A; Haemophilia B
- Focus Registrational; Therapeutic Use
- Acronyms ATLAS-INH
- Sponsors Alnylam Pharmaceuticals; Sanofi Genzyme
- 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. 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