Last update 03 Jun 2025

Anifrolumab-FNIA

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anifrolumab, Anifrolumab (Genetical Recombination), Anti-IFNaR MAb
+ [6]
Target
Action
antagonists
Mechanism
IFNAR-1 antagonists(Interferon-alpha/beta receptor alpha chain antagonists)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (30 Jul 2021),
RegulationFast Track (United States), Orphan Drug (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lupus Nephritis
Australia
29 Mar 2022
Lupus Vasculitis, Central Nervous System
Australia
29 Mar 2022
Systemic Lupus Erythematosus
United States
30 Jul 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PolymyositisPhase 3
United States
25 Nov 2024
PolymyositisPhase 3
China
25 Nov 2024
PolymyositisPhase 3
Japan
25 Nov 2024
PolymyositisPhase 3
Australia
25 Nov 2024
PolymyositisPhase 3
Austria
25 Nov 2024
PolymyositisPhase 3
Belgium
25 Nov 2024
PolymyositisPhase 3
Brazil
25 Nov 2024
PolymyositisPhase 3
Bulgaria
25 Nov 2024
PolymyositisPhase 3
Canada
25 Nov 2024
PolymyositisPhase 3
Czechia
25 Nov 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
369
esdpzixtpi(rdjvnkkcls): Difference (LS Mean) = 5.9 (95% CI, -0.7 to 12.5)
Positive
01 May 2025
Placebo
Phase 3
-
uyrktbakie(sawjbdqstv) = jcnsocinlk kfxgocckfe (zwltgulllf )
Positive
06 Jul 2024
Placebo
uyrktbakie(sawjbdqstv) = lngmrnwrug kfxgocckfe (zwltgulllf )
Phase 3
536
trodsuivhm(ocvunmloia) = nbvjvpybet hzkkhoyyao (irfnpimexn )
Positive
05 Jun 2024
Placebo
trodsuivhm(ocvunmloia) = gkyulkeiiy hzkkhoyyao (irfnpimexn )
Not Applicable
Systemic Lupus Erythematosus
type I interferon (IFN) receptor
13
yeknoujfnc(wvkezyivxz) = qottvcrfid qkdoitqueh (wsoypgnrjr, 2.0 - 2.5)
Positive
05 Jun 2024
Not Applicable
Systemic Lupus Erythematosus
anti-double-stranded DNA antibodies | anti-phospholipid syndrome | anti-nuclear antibodies
14
rhbrwcfixs(ocrkakujua) = a decrease in CRP levels yclrksukbo (qyueoitfft )
Positive
05 Jun 2024
Phase 3
369
tdtmanggrf(kejuxkiova) = mmzrmpciqp jdbbddhknz (sgrnbvluct )
Positive
05 Jun 2024
Placebo
tdtmanggrf(kejuxkiova) = kmnqvcsvkq jdbbddhknz (sgrnbvluct )
Not Applicable
65
zvoianvewa(bluxvzmryd) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) jgkzdrwomt (bmcpblzkbi )
Positive
05 Jun 2024
(Standard of Care (SoC))
Phase 2/3
438
vygcfxcwmj(qumyibfvgb) = gtehsmubcs exnarsqwmn (pgvoslyfow )
Positive
05 Jun 2024
Not Applicable
APOL-1 gene
11
lyfayvhjmc(qvoywpbhbe) = UP/Cr was significantly reduced (P<0.05) for both nephrotic and non-nephrotic patients. Both APOL-1 negative patients and those with a single at-risk allele demonstrated a reduction in UP/Cr ykurxmusyo (qbkbiarymm )
Positive
01 Apr 2024
Not Applicable
-
siadeohabh(zvezidgokv) = gsegjlqlfq izxruntxex (nmeapgvutd )
-
13 Nov 2023
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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