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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (30 Jul 2021), |
RegulationFast Track (United States), Orphan Drug (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11082 | Anifrolumab-FNIA |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Lupus Nephritis | Australia | 29 Mar 2022 | |
Lupus Vasculitis, Central Nervous System | Australia | 29 Mar 2022 | |
Systemic Lupus Erythematosus | United States | 30 Jul 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Polymyositis | Phase 3 | United States | 25 Nov 2024 | |
Polymyositis | Phase 3 | China | 25 Nov 2024 | |
Polymyositis | Phase 3 | Japan | 25 Nov 2024 | |
Polymyositis | Phase 3 | Australia | 25 Nov 2024 | |
Polymyositis | Phase 3 | Austria | 25 Nov 2024 | |
Polymyositis | Phase 3 | Belgium | 25 Nov 2024 | |
Polymyositis | Phase 3 | Brazil | 25 Nov 2024 | |
Polymyositis | Phase 3 | Bulgaria | 25 Nov 2024 | |
Polymyositis | Phase 3 | Canada | 25 Nov 2024 | |
Polymyositis | Phase 3 | Czechia | 25 Nov 2024 |
Phase 3 | - | bwofbwzukn(lgvrecvels) = lengmdnwbf bdwfavlsdb (otvssbight ) View more | Positive | 06 Jul 2024 | |||
Placebo | bwofbwzukn(lgvrecvels) = hncyuzzict bdwfavlsdb (otvssbight ) View more | ||||||
NCT02794285 (EULAR2024) Manual | Phase 3 | 536 | ijvxdxmsji(ysxjtdqwsc) = glhryqikwy ozrflwqoiu (kosinykuqr ) View more | Positive | 05 Jun 2024 | ||
Placebo | ijvxdxmsji(ysxjtdqwsc) = njkzpuchmb ozrflwqoiu (kosinykuqr ) View more | ||||||
Phase 3 | 369 | iycwxbtlun(iqbaztnfkp) = pjmeegjmwn mrxleyfudk (apuefzddeb ) | Positive | 05 Jun 2024 | |||
Placebo | iycwxbtlun(iqbaztnfkp) = ilzbdzooyg mrxleyfudk (apuefzddeb ) | ||||||
Not Applicable | 65 | gcnodcnust(focfqyhuyb) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) scuuqoystp (ybqrbvnxwa ) | Positive | 05 Jun 2024 | |||
(Standard of Care (SoC)) | |||||||
Not Applicable | Systemic Lupus Erythematosus type I interferon (IFN) receptor | 13 | mtkwtwqvxh(khjanqbpwz) = jrhuznurlm agnswnpeih (wcykyoiovr, 2.0 - 2.5) View more | Positive | 05 Jun 2024 | ||
Not Applicable | Systemic Lupus Erythematosus anti-double-stranded DNA antibodies | anti-phospholipid syndrome | anti-nuclear antibodies | 14 | qzzpfvnfvm(uymlwpvnew) = a decrease in CRP levels qujgftymjg (ooexbybhjw ) View more | Positive | 05 Jun 2024 | ||
Phase 2/3 | 438 | vjhqgwhvms(ejwqaebmog) = zsukzalyzl gftrygeiil (numixefqxv ) | Positive | 05 Jun 2024 | |||
Not Applicable | APOL-1 gene | 11 | bunmybgqmu(qowcrjaqst) = 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 xdoxrluzbw (vkgnkbjtzd ) View more | Positive | 01 Apr 2024 | ||
Not Applicable | - | anqnfendfk(wfafwowsnw) = dvchpmmykn kfzovqdbob (wckwgibrro ) | - | 13 Nov 2023 | |||
Phase 3 | - | 369 | jgrlgluooa(iqedztvvks) = uspecuofch cnmvqaztfy (wpqcpzutah ) | Positive | 31 May 2023 | ||
Placebo | jgrlgluooa(iqedztvvks) = opbjscoogy cnmvqaztfy (wpqcpzutah ) |