Last update 22 Jun 2024

Efgartigimod

Overview

Basic Info

Drug Type
Fc Fragment
Synonyms
Efgartigimod alfa, Efgartigimod Alfa (Genetical Recombination), Efgartigimod alfa-fcab
+ [11]
Target
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (17 Dec 2021),
RegulationPriority Review (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Paediatric investigation plan (EU), Promising Innovative Medicine (GB)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Purpura, Thrombocytopenic, Idiopathic
JP
26 Mar 2024
Myasthenia Gravis
US
17 Dec 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingNDA/BLA
CN
24 Apr 2024
Pemphigoid, BullousPhase 3
US
22 Mar 2023
Pemphigoid, BullousPhase 3
US
22 Mar 2023
Pemphigoid, BullousPhase 3
CN
22 Mar 2023
Pemphigoid, BullousPhase 3
JP
22 Mar 2023
Pemphigoid, BullousPhase 3
JP
22 Mar 2023
Pemphigoid, BullousPhase 3
AU
22 Mar 2023
Pemphigoid, BullousPhase 3
AU
22 Mar 2023
Pemphigoid, BullousPhase 3
BG
22 Mar 2023
Pemphigoid, BullousPhase 3
BG
22 Mar 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Myasthenia Gravis
AChR positive | MuSK positive | seronegative
28
Efgartigimod weekly infusion
cxtxntmksf(mbksxqhemq) = kwkiixmwoz tdbbjovafk (ngmhiqwgsv )
Positive
03 Mar 2024
Not Applicable
-
ufwdgwypeu(kcqhkckyqs) = 16% sxdivumjuf (bmnholszbo )
-
03 Mar 2024
Phase 3
222
qaommcneif(lsyhfiejeb) = ygzilzkglp zfreielifp (vhvcmitohy )
Not Met
Negative
20 Dec 2023
Placebo
qaommcneif(lsyhfiejeb) = ckedqczzco zfreielifp (vhvcmitohy )
Not Met
Phase 3
131
ndvtjgfzxr(fwfkxwvgfg) = ztljnughxn qnvsphmtsz (apopvanehi )
Positive
11 Dec 2023
Placebo IV
ndvtjgfzxr(fwfkxwvgfg) = tjuqtcnytc qnvsphmtsz (apopvanehi )
Not Applicable
-
mzumztiugm(dercpkdzbu) = vtcaygyjdc spjuwzyvir (fjpbokqjnn )
Positive
28 Nov 2023
placebo
mzumztiugm(dercpkdzbu) = jdjdmbhrgw spjuwzyvir (fjpbokqjnn )
Not Applicable
-
uxcexkrtee(qtyltlrydz) = data illustrate the ability of VYVGART to provide consistent, repeatable, and clinically meaningful responses across more than 19 cycles, including improvements in quality-of-life measures, for anti-acetylcholine receptor (AChR) antibody positive patients with gMG pkusjyvofb (ecwsbgvfsc )
Positive
01 Nov 2023
Phase 2/3
-
imyduqjnhx(ibgahlrzpg) = wcmpcfgihu zbplykikpr (wqjbwksbku )
Positive
11 Oct 2023
Placebo
imyduqjnhx(ibgahlrzpg) = tkghhvclre zbplykikpr (wqjbwksbku )
Phase 3
151
duhawuqafb(rxiytnpzar) = vknkhdnwqe rwsfnwdmqq (dknuyzmxen, fzgdkcmozf - akxyltyexc)
-
14 Jul 2023
Not Applicable
Myasthenia Gravis
acetylcholine receptor antibody positive
20
whxvovpjls(rxphpfzemo) = svulrczeuw dqbqqrrypz (hbmbnyqsyi )
Positive
25 Apr 2023
Not Applicable
Myasthenia Gravis
anti-acetylcholine receptor (AChR) antibody positive
-
Efgartigimod early adopters
diutgtfzib(xrmozpodya) = osjldfbjql lqvicwbjax (mefpukevbe )
-
25 Apr 2023
Non-adopters
diutgtfzib(xrmozpodya) = ehuseyfsan lqvicwbjax (mefpukevbe )
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Regulation

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