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: 22 Sep 2017
At a glance
- Drugs Fitusiran (Primary)
- Indications Haemophilia A; Haemophilia B
- Focus Registrational; Therapeutic Use
- Acronyms ATLAS-A/B
- Sponsors Alnylam Pharmaceuticals
- 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.
- 07 Sep 2017 Status changed from recruiting to suspended, due to a fatal thrombotic event in a patient with hemophilia A who was receiving fitusiran in a phase 2 open label extension study (258054), according to an Alnylam Pharmaceuticals media release.
- 07 Sep 2017 According to a Sanofi media release, Alnylam has suspended dosing in all ongoing fitusiran studies pending further review of the safety event and development of a risk mitigation strategy.