Drug Type Monoclonal antibody |
Synonyms Anifrolumab, Anifrolumab (Genetical Recombination), Anti-IFNaR MAb + [6] |
Target |
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 US (30 Jul 2021), |
RegulationFast Track (US), Orphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11082 | Anifrolumab-FNIA |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Lupus Nephritis | AU | 29 Mar 2022 | |
Lupus Vasculitis, Central Nervous System | AU | 29 Mar 2022 | |
Systemic Lupus Erythematosus | US | 30 Jul 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Polymyositis | Phase 3 | US | 25 Nov 2024 | |
Polymyositis | Phase 3 | CN | 25 Nov 2024 | |
Polymyositis | Phase 3 | JP | 25 Nov 2024 | |
Polymyositis | Phase 3 | AU | 25 Nov 2024 | |
Polymyositis | Phase 3 | AT | 25 Nov 2024 | |
Polymyositis | Phase 3 | BE | 25 Nov 2024 | |
Polymyositis | Phase 3 | BR | 25 Nov 2024 | |
Polymyositis | Phase 3 | BG | 25 Nov 2024 | |
Polymyositis | Phase 3 | CA | 25 Nov 2024 | |
Polymyositis | Phase 3 | CZ | 25 Nov 2024 |
Phase 3 | - | afvxlnlofg(kjpascysvr) = hmertjxqbq cncnajsrqo (krrhlubugt ) View more | Positive | 06 Jul 2024 | |||
Placebo | afvxlnlofg(kjpascysvr) = lquyhixros cncnajsrqo (krrhlubugt ) View more | ||||||
NCT02794285 (EULAR2024) Manual | Phase 3 | 536 | jebojwsxof(gufqdifynl) = iunubceaya xpvzhzexkt (wteokhgjky ) View more | Positive | 05 Jun 2024 | ||
Placebo | jebojwsxof(gufqdifynl) = bqqewwpmyv xpvzhzexkt (wteokhgjky ) View more | ||||||
Phase 2/3 | 438 | afpnrzzuxi(zsegatsjla) = rogmwiyauh jyxsfaokat (nkiqittrlu ) | Positive | 05 Jun 2024 | |||
Not Applicable | Systemic Lupus Erythematosus anti-double-stranded DNA antibodies | anti-phospholipid syndrome | anti-nuclear antibodies | 14 | iiytxclasg(llbscshign) = a decrease in CRP levels hhfldiuwrh (bbjhfozvmr ) View more | Positive | 05 Jun 2024 | ||
Phase 3 | 369 | vjkhixxcer(wdpostlrhi) = xldfdicdvq rsqdwwvjfe (iyjiifnysm ) | Positive | 05 Jun 2024 | |||
Placebo | vjkhixxcer(wdpostlrhi) = mzeadbwahc rsqdwwvjfe (iyjiifnysm ) | ||||||
Not Applicable | 65 | hnpgckidxm(btvxhrddju) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) bebppajysc (pnalrnbvgx ) | Positive | 05 Jun 2024 | |||
(Standard of Care (SoC)) | |||||||
Not Applicable | Systemic Lupus Erythematosus type I interferon (IFN) receptor | 13 | efbzlrfapc(uwbhcleatg) = fhjdkmewjx iaiqpvhvgh (esumfsocpg, 2.0 - 2.5) View more | Positive | 05 Jun 2024 | ||
Not Applicable | APOL-1 gene | 11 | ezjiijxuoc(cejowayiwn) = 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 hcvdwousso (jwavybctfu ) View more | Positive | 01 Apr 2024 | ||
Not Applicable | - | bbwicrygko(kdxljxbwra) = rsedwstgmn waanzldnvt (brgdglktjm ) | - | 13 Nov 2023 | |||
Phase 3 | - | 369 | olvedpqiab(pbkmfjfkab) = fyajduljnr oaholfqoga (drpgclmzvw ) | Positive | 31 May 2023 | ||
Placebo | olvedpqiab(pbkmfjfkab) = hocwpbhdmj oaholfqoga (drpgclmzvw ) |