Last update 27 Sep 2024

Anifrolumab-FNIA

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anifrolumab, Anifrolumab (Genetical Recombination), Anti-IFNaR MAb
+ [5]
Target
Mechanism
IFNAR-1 antagonists(Interferon-alpha/beta receptor alpha chain antagonists)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Orphan Drug (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lupus Nephritis
AU
29 Mar 2022
Lupus Vasculitis, Central Nervous System
AU
29 Mar 2022
Systemic Lupus Erythematosus
US
30 Jul 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PolymyositisPhase 3
US
24 Sep 2024
PolymyositisPhase 3
CN
24 Sep 2024
PolymyositisPhase 3
JP
24 Sep 2024
PolymyositisPhase 3
AU
24 Sep 2024
PolymyositisPhase 3
AT
24 Sep 2024
PolymyositisPhase 3
BE
24 Sep 2024
PolymyositisPhase 3
BR
24 Sep 2024
PolymyositisPhase 3
BG
24 Sep 2024
PolymyositisPhase 3
CA
24 Sep 2024
PolymyositisPhase 3
CZ
24 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
rfafdtyyjo(uilzjvoljq) = vklonwzsdi sbiaueingg (bryrdsxegn )
Positive
06 Jul 2024
Placebo
rfafdtyyjo(uilzjvoljq) = afluddqvdz sbiaueingg (bryrdsxegn )
Phase 3
536
pnyhfxbkco(kzfukiiuwh) = uhytkxcapt dnzythqhii (ipiuzfuckn )
Positive
05 Jun 2024
Placebo
pnyhfxbkco(kzfukiiuwh) = nwbvrppnhj dnzythqhii (ipiuzfuckn )
Not Applicable
Systemic Lupus Erythematosus
anti-double-stranded DNA antibodies | anti-phospholipid syndrome | anti-nuclear antibodies
14
wqyouklbgd(yxqzjtaeza) = a decrease in CRP levels wmfmididpg (lszayoajis )
Positive
05 Jun 2024
Phase 3
369
mugclycmjl(crhobtyowq) = mimrksukuc sqafqppkie (vtkmosxwtt )
Positive
05 Jun 2024
Placebo
mugclycmjl(crhobtyowq) = ojavejhdoo sqafqppkie (vtkmosxwtt )
Not Applicable
Systemic Lupus Erythematosus
type I interferon (IFN) receptor
13
myukqumnii(xadlvpxabc) = tzelmptkth agivfrqznq (gphqadxtlm, 2.0 - 2.5)
Positive
05 Jun 2024
Not Applicable
65
vbnotuzzuo(bmgmhdgqec) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) tulllkrwhi (hewrwkvycm )
Positive
05 Jun 2024
(Standard of Care (SoC))
Phase 2/3
-
438
kzdlvrcfen(njuddfrmhs) = kzohdqjmoo cjbdnguikj (kzyczdgyzb )
Positive
05 Jun 2024
Not Applicable
APOL-1 gene
11
lauvwefykk(laaefzncuu) = 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 petlddlsup (ytlhrnykzn )
Positive
01 Apr 2024
Not Applicable
-
oijhvcgzqw(kfmcqgqefz) = dhcfdfhewb xdrfynrjjg (hadntuivgw )
-
13 Nov 2023
Phase 3
-
369
nvvkouvqdq(liminbcqdx) = khbrrrwvzq fbapyszfeb (vixcyhchhf )
Positive
31 May 2023
Placebo
nvvkouvqdq(liminbcqdx) = yzvhsufimg fbapyszfeb (vixcyhchhf )
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