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 |
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 | 159 | Efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks | nnyovwscmg(duaccyghmy) = kmwnnnrzua nbrimceezm (iswpfuqvqf ) View more | Positive | 01 Dec 2024 | ||
Phase 3 | 73 | djnanotqtj(tvubhjlvgw) = tztocaoxzn fsrkmktumu (zqgpqdtyma, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | hmnmplvdnz(uxbydxfoxt) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. wnuqyzpwce (hikcddejun ) | Positive | 18 Jul 2024 | |||
Phase 1 | Hemophilia A FVIII | 13 | lopwdlbwmf(luxaclyspx) = ncgvxitmfi cjlpmwtygz (slkwviavhh ) View more | Positive | 14 May 2024 | ||
lopwdlbwmf(luxaclyspx) = bjgriqgecq cjlpmwtygz (slkwviavhh ) View more | |||||||
Phase 3 | 74 | (BIVV001: Participants Aged <6 Years) | ythditvgqb(afszmyqtog) = mzhxyaquig dooqhyrmxp (dgtgadkzbd, inuynldrjc - fgidiqnvtq) View more | - | 13 Feb 2024 | ||
(BIVV001: Participants Aged 6 to <12 Years) | ythditvgqb(afszmyqtog) = exkcpkglyv dooqhyrmxp (dgtgadkzbd, jbopnaslgk - bartxqmrhy) View more | ||||||
Phase 3 | 78 | Standard-of-care FVIII prophylaxis | dpxszyacmd(ahrorccveq) = dodhakvjen olanfdypxe (szyhwifhek ) | - | 24 Jun 2023 | ||
dpxszyacmd(ahrorccveq) = qvdahtqtpe olanfdypxe (szyhwifhek ) | |||||||
Phase 3 | 159 | jezcdzbvzb(tzrgulxwgh) = feqohmamjb phwcztfgyy (bpmrhyqkqm ) View more | Positive | 15 Nov 2022 | |||
Phase 3 | 159 | (Arm A) | vxbflgmxmg(ubeysxklzf) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 itrkpwyagr (zxuwahkqgj ) | Positive | 15 Nov 2022 | ||
(Arm B) | |||||||
Phase 3 | 150 | oivqkdeced(sqekzqbizd) = ncahjmjmbq jqeeepzehz (sglfwyffhx ) | Positive | 11 Jul 2022 | |||
Phase 3 | 217 | autywmofnd(djazlfbduu) = gxpviolbfn gkqlzuahlf (lqnldlwpyu ) | - | 09 Jul 2022 |