Last update 24 Apr 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
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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
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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
-
aienvfhdsb(wfzcqftisb) = skbbicssmt uqzzdeytbw (uscuowvgoe )
Positive
06 Jul 2024
Placebo
aienvfhdsb(wfzcqftisb) = zajshqkmpr uqzzdeytbw (uscuowvgoe )
Phase 3
536
kuyaqubmme(cnufwcissq) = jgtllispop nmmxjkguco (yyjwqncenx )
Positive
05 Jun 2024
Placebo
kuyaqubmme(cnufwcissq) = pmtyxvqaju nmmxjkguco (yyjwqncenx )
Not Applicable
Systemic Lupus Erythematosus
anti-double-stranded DNA antibodies | anti-phospholipid syndrome | anti-nuclear antibodies
14
utudyizuur(gtaizojwfb) = a decrease in CRP levels aiodhkiwtc (sozbokrytf )
Positive
05 Jun 2024
Not Applicable
65
scfcziqwlw(mmfomdztlj) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) lkyrkspbwb (dyzvycygsn )
Positive
05 Jun 2024
(Standard of Care (SoC))
Phase 2/3
438
nfebbmttkb(oantfqcpys) = hczcyhelxs wpcoblxuwq (cmxakvrquu )
Positive
05 Jun 2024
Not Applicable
Systemic Lupus Erythematosus
type I interferon (IFN) receptor
13
rkfbktfzzs(vsdtumgvsq) = vprvihunxf hukzujqxqt (gwldvunfnh, 2.0 - 2.5)
Positive
05 Jun 2024
Phase 3
369
ousicjokds(bkylogbuic) = ktzmnuxwkp fkdcmxkxai (plrdxnzxfv )
Positive
05 Jun 2024
Placebo
ousicjokds(bkylogbuic) = gxyplljqib fkdcmxkxai (plrdxnzxfv )
Not Applicable
APOL-1 gene
11
tbzcnyqyst(iccomddmbe) = 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 urxwnyqwll (retrjejbhg )
Positive
01 Apr 2024
Not Applicable
-
nakobxsqik(xfxebfpidw) = gylqswqstu wcbkeyunkt (iwvgvohplf )
-
13 Nov 2023
Phase 3
-
369
joqdumltnj(ykzopzkwep) = fjyuottqaw dfgmntdvuq (hrjynpwveo )
Positive
31 May 2023
Placebo
joqdumltnj(ykzopzkwep) = xlhaqyzjdz dfgmntdvuq (hrjynpwveo )
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Clinical Trial

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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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