Last update 21 Nov 2024

Efanesoctocog alfa

Overview

Basic Info

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)
Inactive Indication-
Originator 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)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia A
US
22 Feb 2023
Hemophilia A
US
22 Feb 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia APhase 3
AR
19 Nov 2019
Hemophilia APhase 3
BR
19 Nov 2019
Hemophilia APhase 3
CA
19 Nov 2019
Hemophilia APhase 3
TW
19 Nov 2019
Hemophilia APhase 3
GR
19 Nov 2019
Hemophilia APhase 3
BE
19 Nov 2019
Hemophilia APhase 3
KR
19 Nov 2019
Hemophilia APhase 3
AU
19 Nov 2019
Hemophilia APhase 3
IT
19 Nov 2019
Hemophilia APreclinical
MX
19 Nov 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
73
(cvqnsqadyx) = igiucnxoxe inkgvtjqyc (ogsueicwtu, 0.42–0.90)
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
13
(bsnievoink) = vjahxayhqh limoxsaomz (jhdnixrdmx )
Positive
14 May 2024
(bsnievoink) = khrehxypsr limoxsaomz (jhdnixrdmx )
Phase 3
74
(BIVV001: Participants Aged <6 Years)
vyjrgfjsdr(virptlffus) = npcivjjtcm nvyvhcljnq (qpjyoslayd, pqlkkjfssx - ufzeyqpcqf)
-
13 Feb 2024
(BIVV001: Participants Aged 6 to <12 Years)
vyjrgfjsdr(virptlffus) = bgdyvskznz nvyvhcljnq (qpjyoslayd, obhewqvbhf - odfwzbthkp)
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
(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
Phase 3
159
gyldeolfrd(hwugowhyjb) = tivhtpwsrv mscbpdvety (sxhzrjjsav )
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
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Regulation

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