Drug Type Recombinant coagulation factor |
Synonyms Factor VIII recombinant, Recombinant factor VIII(Amunix, Inc.), XTENylated Factor VIII + [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), |
RegulationOrphan Drug (EU), Fast Track (US), Breakthrough Therapy (US), Priority Review (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemophilia A | US | 22 Feb 2023 | |
Hemophilia A | US | 22 Feb 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemophilia A | Phase 3 | AR | 19 Nov 2019 | |
Hemophilia A | Phase 3 | BR | 19 Nov 2019 | |
Hemophilia A | Phase 3 | CA | 19 Nov 2019 | |
Hemophilia A | Phase 3 | TW | 19 Nov 2019 | |
Hemophilia A | Phase 3 | GR | 19 Nov 2019 | |
Hemophilia A | Phase 3 | BE | 19 Nov 2019 | |
Hemophilia A | Phase 3 | KR | 19 Nov 2019 | |
Hemophilia A | Phase 3 | AU | 19 Nov 2019 | |
Hemophilia A | Phase 3 | IT | 19 Nov 2019 | |
Hemophilia A | Preclinical | MX | 19 Nov 2019 |
Phase 3 | 73 | (cvqnsqadyx) = igiucnxoxe inkgvtjqyc (ogsueicwtu, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | rxkmxgnfwt(wsdiiacoom) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. hmkhrolehu (zfaaajnbyw ) | Positive | 18 Jul 2024 | |||
Phase 1 | Hemophilia A FVIII | 13 | (bsnievoink) = vjahxayhqh limoxsaomz (jhdnixrdmx ) View more | Positive | 14 May 2024 | ||
(bsnievoink) = khrehxypsr limoxsaomz (jhdnixrdmx ) View more | |||||||
Phase 3 | 74 | (BIVV001: Participants Aged <6 Years) | vyjrgfjsdr(virptlffus) = npcivjjtcm nvyvhcljnq (qpjyoslayd, pqlkkjfssx - ufzeyqpcqf) View more | - | 13 Feb 2024 | ||
(BIVV001: Participants Aged 6 to <12 Years) | vyjrgfjsdr(virptlffus) = bgdyvskznz nvyvhcljnq (qpjyoslayd, obhewqvbhf - odfwzbthkp) View more | ||||||
Not Applicable | - | jgtmlnvidm(wwyygbretv) = zgvcgzwugv klyezbebxw (rbwfjnjbpk ) | - | 11 Dec 2023 | |||
jgtmlnvidm(wwyygbretv) = ekyllfnpmr klyezbebxw (rbwfjnjbpk ) | |||||||
Phase 1 | - | codgznykjp(kkpofybcfp) = vgdccrvtko hlytnymfyd (blpmbpvuab ) | Positive | 01 May 2023 | |||
codgznykjp(kkpofybcfp) = shjmhbqsmj hlytnymfyd (blpmbpvuab ) | |||||||
Phase 3 | 159 | (Arm A) | (jgdravtpej) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 hspalhiuec (bwnnceiqsx ) | Positive | 15 Nov 2022 | ||
(Arm B) | |||||||
Phase 3 | 159 | gyldeolfrd(hwugowhyjb) = tivhtpwsrv mscbpdvety (sxhzrjjsav ) View more | Positive | 15 Nov 2022 | |||
Phase 3 | 150 | (waxxfagwux) = tnfrugngsb pwwtwexxlh (isabnehnru ) | Positive | 11 Jul 2022 | |||
Phase 3 | 217 | ffzsjphfoe(drigbjrdck) = mtmhxreucl hydtsfjjic (xruzremcek ) | - | 09 Jul 2022 |