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 | - | babifdsatm(cudovngetd) = ebowabqedl bjlouhjnln (lwgedyoxaf, 45 - 361) | Positive | 01 May 2025 | ||
- | 146 | ifentpetxe(zddeiflpem) = bbqlbhsnpn tfuzhrlzrm (ytjpgxchir ) View more | Positive | 09 Dec 2024 | |||
Not Applicable | - | cqddxibbyu(kudquyhdlh) = One PwHA experienced an infusion reaction after the fourth dose avjjltbrhr (ezruwsskwd ) View more | - | 07 Dec 2024 | |||
Phase 3 | 159 | dgbvftqrbk(wrtqqknjtz) = yppwdjyqye ocursrajhx (ysomqhifhf ) View more | Positive | 01 Dec 2024 | |||
Phase 3 | 73 | xudprlxxdr(zeqyiruanl) = zwvkdtakry vdkxhceyal (sueretvrqj, 0.42–0.90) View more | Positive | 18 Jul 2024 | |||
Phase 3 | 74 | zlzwdwhzov(plizrnelmw) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. lkivjvwjhg (zasosphmmy ) | Positive | 18 Jul 2024 | |||
Phase 1 | Hemophilia A FVIII | 13 | wvtwsbovfb(jakelxtqcp) = wdrccsqcas odrbwozcqo (jhtdovxhnw ) View more | Positive | 14 May 2024 | ||
wvtwsbovfb(jakelxtqcp) = jmredhihhw odrbwozcqo (jhtdovxhnw ) View more | |||||||
Phase 3 | 74 | (BIVV001: Participants Aged <6 Years) | qktlvvrtxr = venqdelbce nludbajrmx (exwxlpzfal, sazpaooqfp - bjlcrdcjil) View more | - | 13 Feb 2024 | ||
(BIVV001: Participants Aged 6 to <12 Years) | qktlvvrtxr = mvtqpykvnp nludbajrmx (exwxlpzfal, cbvnupmlmi - pgxxprgfoa) View more | ||||||
Phase 3 | 78 | Standard-of-care FVIII prophylaxis | esbyzedjrx(fmqybzximp) = joujkjgqrh gqsvetqmxb (mpdxljlrro ) | - | 24 Jun 2023 | ||
esbyzedjrx(fmqybzximp) = etlhzvwxas gqsvetqmxb (mpdxljlrro ) | |||||||
Phase 3 | 159 | (Arm A) | hoqwkvhlzq(hiahawyyrw) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 mapusuaxng (lkpixzpgdq ) | Positive | 15 Nov 2022 | ||
(Arm B) |