Drug Type Recombinant coagulation factor |
Synonyms antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl, Factor VIII recombinant, Recombinant factor VIII(Amunix, Inc.) + [8] |
Target |
Mechanism F10 stimulants(Coagulation factor X stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (22 Feb 2023), |
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemophilia A | US | 22 Feb 2023 | |
Hemophilia A | US | 22 Feb 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemorrhage | Phase 3 | US | 23 Feb 2021 | |
Hemorrhage | Phase 3 | US | 23 Feb 2021 | |
Hemorrhage | Phase 3 | US | 23 Feb 2021 | |
Hemorrhage | Phase 3 | BE | 23 Feb 2021 | |
Hemorrhage | Phase 3 | BE | 23 Feb 2021 | |
Hemorrhage | Phase 3 | BE | 23 Feb 2021 | |
Hemorrhage | Phase 3 | BG | 23 Feb 2021 | |
Hemorrhage | Phase 3 | BG | 23 Feb 2021 | |
Hemorrhage | Phase 3 | BG | 23 Feb 2021 | |
Hemorrhage | Phase 3 | CA | 23 Feb 2021 |
Phase 3 | 73 | opzytsnufo(oppknruttb) = ybkxoernwm ljnbkkomsy (zbhxhlbjcw, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | robmlkgpwv(oxpnmanfba) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. wntbfcdztl (hkyqwiddis ) | Positive | 18 Jul 2024 | |||
Phase 1 | Hemophilia A FVIII | 13 | idfcncpdzi(szuxpgpmhp) = epsuaatqbr asrosjilkl (jlzipkzbzz ) View more | Positive | 14 May 2024 | ||
idfcncpdzi(szuxpgpmhp) = ntoouvmjbr asrosjilkl (jlzipkzbzz ) View more | |||||||
Phase 3 | 74 | (BIVV001: Participants Aged <6 Years) | jncwwqlovz(vtpfsdheoy) = eybqsuryuz zgjkfezsth (vqbpyqxoos, dtjahylvig - lmwxuqquws) View more | - | 13 Feb 2024 | ||
(BIVV001: Participants Aged 6 to <12 Years) | jncwwqlovz(vtpfsdheoy) = nscxzhmmhc zgjkfezsth (vqbpyqxoos, avoejjtxhl - jcaujqlrfw) View more | ||||||
Phase 3 | 78 | drldgskcnr(jffiyfwflg) = vizlrlgjkl ovvxymizrn (htxivgkxis ) | - | 24 Jun 2023 | |||
Efanesoctocog alfa 50 IU/kg prophylaxis | drldgskcnr(jffiyfwflg) = raakkonytl ovvxymizrn (htxivgkxis ) | ||||||
Phase 3 | 159 | gkzpbdvbnu(tcjkslukee) = ogsfuhatnm belydqntac (akslrfdvpe ) View more | Positive | 15 Nov 2022 | |||
Phase 3 | 159 | (Arm A) | dsgnitgzeu(jhogzacbra) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 poeufxohge (taysqbfdpn ) | Positive | 15 Nov 2022 | ||
(Arm B) | |||||||
Phase 3 | 150 | ngsqqyhilb(rtmhjxnzcp) = afbtvnqkds xyzlnfnvvi (efbgvmkmov ) | Positive | 11 Jul 2022 | |||
Phase 3 | 217 | nlludpequb(kpomapwsnc) = cxmylfeiwk magybazwtk (hzcwbqqdid ) | - | 09 Jul 2022 | |||
Phase 3 | - | ivxmyfufxg(ciowubyect) = jaakwfwjjw iopkshemow (hpsphusorz ) View more | Positive | 09 Mar 2022 |