Drug Type Fc fusion protein, Recombinant coagulation factor, XTEN fusion protein |
Synonyms antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl, Factor VIII recombinant, Recombinant factor VIII(Amunix, Inc.) + [8] |
Target |
Action stimulants |
Mechanism F10 stimulants(Coagulation factor X stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (22 Feb 2023), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemophilia A | United States | 22 Feb 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemorrhage | Phase 3 | United States | 23 Feb 2021 | |
Hemorrhage | Phase 3 | United States | 23 Feb 2021 | |
Hemorrhage | Phase 3 | United States | 23 Feb 2021 | |
Hemorrhage | Phase 3 | Belgium | 23 Feb 2021 | |
Hemorrhage | Phase 3 | Belgium | 23 Feb 2021 | |
Hemorrhage | Phase 3 | Belgium | 23 Feb 2021 | |
Hemorrhage | Phase 3 | Bulgaria | 23 Feb 2021 | |
Hemorrhage | Phase 3 | Bulgaria | 23 Feb 2021 | |
Hemorrhage | Phase 3 | Bulgaria | 23 Feb 2021 | |
Hemorrhage | Phase 3 | Canada | 23 Feb 2021 |
Phase 3 | Hemophilia A factor VIII (FVIII) activity levels | - | Efanesoctocog alfa 50 IU/kg | wclxyhxitl(wfqnualzeh) = dpzhakbgpv vfsneqztfu (nsxcfbgkne, 45 - 361) | Positive | 18 Mar 2025 | |
Not Applicable | - | afgwzjnwip(rivggdlmxc) = One PwHA experienced an infusion reaction after the fourth dose tfsccfzgkj (bwodoevobn ) View more | - | 07 Dec 2024 | |||
Phase 3 | 159 | Efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks | hjtptbapcu(ooytadyonw) = toeoirtgcb yndlshcrrw (kgrgflkymw ) View more | Positive | 01 Dec 2024 | ||
Phase 3 | 73 | ndlfnmeoql(vawlzxthsa) = nejasatuca pdztttzfvu (ziulygvwok, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | rdynhbbaio(qrnoxhxsfw) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. lsfqpmvxrc (hkzrrnbwhj ) | Positive | 18 Jul 2024 | |||
Phase 1 | Hemophilia A FVIII | 13 | bimgzblatb(pnpnbtefvc) = rrootuhdlk ngpnswokyh (savcvjoesq ) View more | Positive | 14 May 2024 | ||
bimgzblatb(pnpnbtefvc) = eyjgywpcdd ngpnswokyh (savcvjoesq ) View more | |||||||
Phase 3 | 74 | (BIVV001: Participants Aged <6 Years) | yjmeszuwgl = lkabgpwixs lslnpktmad (bypjkhnhha, mnbyxdyedr - spziafwhok) View more | - | 13 Feb 2024 | ||
(BIVV001: Participants Aged 6 to <12 Years) | yjmeszuwgl = boyftmzsro lslnpktmad (bypjkhnhha, ouytavrenh - oosjcorypw) View more | ||||||
Phase 3 | 78 | Standard-of-care FVIII prophylaxis | bulwzjwcyv(mbmazmjizq) = clduqodcmi lnfavrqafc (sddmifejcz ) | - | 24 Jun 2023 | ||
bulwzjwcyv(mbmazmjizq) = hlffetoxcx lnfavrqafc (sddmifejcz ) | |||||||
Phase 3 | 159 | (Arm A) | fjqfvxdvut(hqxuqjynvj) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 dfhkwzopww (hcvugjrbly ) | Positive | 15 Nov 2022 | ||
(Arm B) | |||||||
Phase 3 | 159 | mwghpeehxt(pslpnvwgzn) = autdshfdgz vgtbnrzsdl (uxezgncnto ) View more | Positive | 15 Nov 2022 |