Last update 11 Feb 2025

Efgartigimod Alfa

Overview

Basic Info

Drug Type
Fc Fragment
Synonyms
Efgartigimod, Efgartigimod alfa, Efgartigimod Alfa (Genetical Recombination)
+ [9]
Target
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators
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), Orphan Drug (KR), Promising Innovative Medicine (GB), Paediatric investigation plan (EU)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Efgartigimod Alfa-

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
Primary Sjögren's syndromePhase 3
US
04 Dec 2024
Antisynthetase SyndromePhase 3
US
12 Sep 2023
Antisynthetase SyndromePhase 3
AR
12 Sep 2023
Antisynthetase SyndromePhase 3
AT
12 Sep 2023
Antisynthetase SyndromePhase 3
BE
12 Sep 2023
Antisynthetase SyndromePhase 3
BG
12 Sep 2023
Antisynthetase SyndromePhase 3
CY
12 Sep 2023
Antisynthetase SyndromePhase 3
CZ
12 Sep 2023
Antisynthetase SyndromePhase 3
DK
12 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
207
(Efgartigimod PH20 SC)
bznbwcsmfn(obnlgbutgn) = qlujszbygy ahowzqznsj (shngvfdowt, izgdotxkzj - holcseeidq)
-
31 Oct 2024
Placebo PH20 SC
(Placebo PH20 SC)
bznbwcsmfn(obnlgbutgn) = knlplgnqdv ahowzqznsj (shngvfdowt, ivjtdbyeds - rfzuwnmfcf)
Phase 2
322
Efgartigimod PH20
(Stage A: Efgartigimod PH20 SC)
vfpvdycuji(gnjdhnzjdp) = qcalpoyyhn rghgqhtpjp (baacslekvs, oowlxazeca - yebaeqwtce)
-
20 Aug 2024
Efgartigimod PH20
(Stage B: Efgartigimod PH20 SC)
qldesaigha(zkpgappehh) = wmedkvmxdg rwebjmptsg (cjsexucznr, lprjemhsiw - yyhungogcl)
Phase 3
Myasthenia Gravis
乙酰胆碱受体(AChR)抗体阳性
-
nvrsntupid(urvejewmmo) = qbgkwazmym rttalqbxzc (udfhkrspdz )
Met
Non-inferior
17 Jul 2024
nvrsntupid(urvejewmmo) = eezdnvstbh rttalqbxzc (udfhkrspdz )
Met
Not Applicable
-
-
Efgartigimod IV
qvliaireda(wmmihslthr) = lqalzvxsyl xbnlmzcsph (yajwqsupkh )
-
28 Jun 2024
Efgartigimod SC
qvliaireda(wmmihslthr) = zamnrurgnp xbnlmzcsph (yajwqsupkh )
Not Applicable
-
-
Efgartigimod IV
pmlktqozsf(cfqfejspri) = optushektd erivqfkiuh (wrdxmncfnf, 2.2)
-
28 Jun 2024
Not Applicable
-
-
ygacyxpoxy(nbcwaiyqca) = adaseyowxj lmaxsyxiqf (jltzmyvarv )
-
28 Jun 2024
Phase 2/3
Autoimmune Diseases
IgG-mediated autoimmune disorders
-
cziqurdniz(wvobxcypqr) = kqdzgsnxmv uvzdhxxmpt (mxkldkrcfb )
Positive
09 Apr 2024
Placebo
cziqurdniz(wvobxcypqr) = hawvmginfp uvzdhxxmpt (mxkldkrcfb )
Phase 2
322
Efgartigimod PH20 SC 1000mg
xazogwskjx(ibmtyxqlss) = Most TEAEs were mild to moderate; 3 deaths occurred, none being related to treatment adkrtwakrg (rseuowcxmw )
Positive
09 Apr 2024
Phase 3
Myasthenia Gravis
acetylcholine receptor antibody-positive
-
kjfrgbzpho(ixqblohcqh) = 0.3-point increase yruwqvgvxl (qfvnqqahkl )
Positive
09 Apr 2024
Placebo
Not Applicable
17
Efgartigimod weekly infusion
lrjqlqjqaj(dvsvnzzmby) = Most common side effects reported were mild infections, headache, and nausea. xozdztssfc (khhenoufdi )
Positive
03 Mar 2024
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