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
Phase of Trial: Phase III
Latest Information Update: 09 Nov 2017
At a glance
- Drugs Fitusiran (Primary)
- Indications Haemophilia A; Haemophilia B
- Focus Registrational; Therapeutic Use
- Acronyms ATLAS-A/B
- Sponsors Alnylam Pharmaceuticals
- 09 Nov 2017 According to an Alnylam Pharmaceuticals media release, after a Type A meeting with the U.S. Food and Drug Administration (FDA), the FDA will now consider removal of the clinical hold upon final review of the amended protocols and other trial materials.
- 09 Nov 2017 According to an Alnylam Pharmaceuticals media release, alignment reached with FDA on amended safety measures and risk mitigation strategy to enable resumption of fitusiran clinical program. Reinitiation of dosing will be announced around year end.
- 07 Sep 2017 According to an Alnylam Pharmaceuticals media release, based on overall consideration of fitusirans benefit-risk profile, the company expects to resume dosing upon agreement with global regulatory authorities and with appropriate protocol amendments in place for enhanced patient safety monitoring, in all of its clinical studies (Phase 2 OLE and ATLAS Phase 3 program) as soon as possible, potentially as early as late 2017.