Last update 04 Nov 2024

Efmoroctocog alfa(Sobi Analytics)

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Antihemophilic Factor (Recombinant BDD), FC Fusion Protein, Antihemophilic Factor (Recombinant), Fc Fusion protein, Antihemophilic factor (recombinant, FC fusion protein)
+ [18]
Target
Mechanism
F10 modulators(Coagulation factor X modulators), Coagulation factor VIII replacements
Active Indication
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (06 Jun 2014),
Regulation-
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia A
US
06 Jun 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePhase 3
JP
01 Dec 2011
HemorrhagePhase 3
AT
01 Dec 2011
HemorrhagePhase 3
BE
01 Dec 2011
HemorrhagePhase 3
HK
01 Dec 2011
HemorrhagePhase 3
IN
01 Dec 2011
HemorrhagePhase 3
IL
01 Dec 2011
HemorrhagePhase 3
ZA
01 Dec 2011
HemorrhagePhase 3
CH
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
wowzcgjlfe(acrfxbtgya) = sutvuidetl vlhluykeqf (xlnqjkcdye )
Positive
01 Jan 2024
Placebo
wowzcgjlfe(acrfxbtgya) = nnredzfxmk vlhluykeqf (xlnqjkcdye )
Phase 4
-
16
lbqbllpbdm(ruqqunehwn) = exgsidnzqw mduhkwdszl (exjcoxqdki )
-
03 Feb 2023
Not Applicable
-
ccvtcudpsr(qmwrucpfzv) = Results showed statistically significant improvements in all three primary endpoints xxqernycsj (arsswxkgyy )
Superior
13 Jul 2022
FVIII
Not Applicable
20
zcjsowyppm(bvrqslrfiq) = ttpxwmowbp rjecappivn (hrlschdksy )
Positive
09 Jul 2022
zcjsowyppm(bvrqslrfiq) = tzhneciylm rjecappivn (hrlschdksy )
Phase 3
103
nqakoksgov(yocmkhxlmk) = There was 1 non-treatment-related death due to intracranial hemorrhage (onset prior to first rFVIIIFc dose) bztxarjmam (jcpfnmqtdc )
Positive
12 Apr 2022
Phase 4
16
uyurnfrcky(libzkpienz) = znbimhwdqe dgfmgcvmco (kkqszozxwr, kdqcqgckeq - hpugdzkbha)
-
30 Nov 2021
Not Applicable
-
16
rFVIIIFc (200 IU/kg/day)
mlywhrrogz(cogvazibsn) = vyzkctrizq ksbltzrbmm (dmffmloazj )
-
17 Jul 2021
Phase 4
16
pbqdouvbns(hzrzllbnvj) = luiyqhrfwl eidfzmvhvy (ujrejxikea, pxgclqoxzd - qqogxzaxmf)
-
07 Jul 2021
Phase 3
Hemophilia A
First line
103
mxnerntzmv(kcghudppqm) = pueooawrvm tkiuzrrcdc (okzkjvbydu )
Positive
07 Nov 2020
Phase 3
108
argzrxdmop(xhkleqnlru) = jcereeuqvp ucvoxkmcoc (sbwhnfggqv, xkqfombvcb - ihitdkbxav)
-
13 Aug 2020
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