JP2022536739A - 関節リウマチのための皮下トシリズマブの改良された投薬量 - Google Patents

関節リウマチのための皮下トシリズマブの改良された投薬量 Download PDF

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JP2022536739A
JP2022536739A JP2021573732A JP2021573732A JP2022536739A JP 2022536739 A JP2022536739 A JP 2022536739A JP 2021573732 A JP2021573732 A JP 2021573732A JP 2021573732 A JP2021573732 A JP 2021573732A JP 2022536739 A JP2022536739 A JP 2022536739A
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tocilizumab
antibody
administered
received
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JP2021573732A
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Japanese (ja)
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JP2022536739A5 (https=
Inventor
チェイ－アイ・チェン
ウェンフイ・ウェイ
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Publication of JP2022536739A publication Critical patent/JP2022536739A/ja
Publication of JP2022536739A5 publication Critical patent/JP2022536739A5/ja
Priority to JP2025207503A priority Critical patent/JP2026032195A/ja
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2021573732A 2019-06-12 2020-06-11 関節リウマチのための皮下トシリズマブの改良された投薬量 Pending JP2022536739A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025207503A JP2026032195A (ja) 2019-06-12 2025-11-28 関節リウマチのための皮下トシリズマブの改良された投薬量

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962860611P 2019-06-12 2019-06-12
US62/860,611 2019-06-12
EP20305192.5 2020-02-27
EP20305192 2020-02-27
PCT/US2020/037325 WO2020252214A1 (en) 2019-06-12 2020-06-11 Modified dosage of subcutaneous tocilizumab for rheumatoid arthritis

Related Child Applications (1)

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JP2025207503A Division JP2026032195A (ja) 2019-06-12 2025-11-28 関節リウマチのための皮下トシリズマブの改良された投薬量

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JP2022536739A true JP2022536739A (ja) 2022-08-18
JP2022536739A5 JP2022536739A5 (https=) 2023-06-16

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JP2021573732A Pending JP2022536739A (ja) 2019-06-12 2020-06-11 関節リウマチのための皮下トシリズマブの改良された投薬量
JP2025207503A Pending JP2026032195A (ja) 2019-06-12 2025-11-28 関節リウマチのための皮下トシリズマブの改良された投薬量

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JP2025207503A Pending JP2026032195A (ja) 2019-06-12 2025-11-28 関節リウマチのための皮下トシリズマブの改良された投薬量

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Country Link
US (1) US20220242959A1 (https=)
EP (1) EP3983071A1 (https=)
JP (2) JP2022536739A (https=)
KR (1) KR20230047944A (https=)
CN (1) CN115003382A (https=)
AU (1) AU2020290484A1 (https=)
BR (1) BR112021025060A2 (https=)
CA (1) CA3143261A1 (https=)
CO (1) CO2022000064A2 (https=)
IL (1) IL288690A (https=)
MA (1) MA56190A (https=)
MX (1) MX2021015336A (https=)
WO (1) WO2020252214A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11202111742QA (en) 2019-04-24 2021-11-29 Sanofi Biotechnology Methods of diagnosis and treatment of rheumatoid arthritis
CA3142710A1 (en) 2019-06-04 2020-12-10 Sanofi Biotechnology Compositions and methods for treating pain in subjects with rheumatoid arthritis
CN115825415B (zh) * 2022-09-28 2023-07-14 珠海重链生物科技有限公司 阻断剂和体外免疫诊断产品、应用

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2401040A (en) 2003-04-28 2004-11-03 Chugai Pharmaceutical Co Ltd Method for treating interleukin-6 related diseases
KR20190120439A (ko) * 2010-11-08 2019-10-23 제넨테크, 인크. 피하 투여용 항―ｉｌ―6 수용체 항체

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
"A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizu", ANNALS OF THE RHEUMATIC DISEASES, vol. 73, no. 1, JPN6024019287, 2014, pages 69 - 74, ISSN: 0005468719 *
"ES02. Relatonship between fatigue and IL 6, diseas activity, depression in patients treated with toc", RHEUMATOLOGY, vol. Vol.51, Supplement 1, JPN6024019283, 2012, pages 34, ISSN: 0005468723 *
"Histrory Changes for Study: NCT00977106 TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Pat", CLINICALTRIALS.GOV ARCHIVES, JPN6024019285, 15 September 2014 (2014-09-15), ISSN: 0005468721 *
"Histrory Changes for Study: NCT01194414 A Study to Compare Subcutaneous Versus Intravenous Administr", CLINICALTRIALS.GOV ARCHIVE, JPN6024019288, 11 May 2016 (2016-05-11), ISSN: 0005468718 *
"Histrory Changes for Study: NCT01988012 A Study of the Efficacy and Safety of Tocilizumab in Adults", CLINICALTRIALS.GOV ARCHIVES, JPN6024019282, 17 January 2017 (2017-01-17), ISSN: 0005468724 *
"Safety and efficacy of tocilizumab, an anti-IL-6-receptor monoclonal antibody, in patients with poly", MODERN RHEUMATOLOGY, vol. 22, no. 1, JPN6024019286, 2012, pages 109 - 115, ISSN: 0005468720 *
"Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-frame work phase 4 study", RHEUMATOLOGY, vol. 57, no. 3, JPN6024019284, 2018, pages 499 - 507, ISSN: 0005468722 *

Also Published As

Publication number Publication date
BR112021025060A2 (pt) 2022-02-22
JP2026032195A (ja) 2026-02-25
MX2021015336A (es) 2022-10-21
WO2020252214A1 (en) 2020-12-17
IL288690A (en) 2022-02-01
KR20230047944A (ko) 2023-04-10
CN115003382A (zh) 2022-09-02
CA3143261A1 (en) 2020-12-17
CO2022000064A2 (es) 2022-04-08
US20220242959A1 (en) 2022-08-04
EP3983071A1 (en) 2022-04-20
MA56190A (fr) 2022-04-20
AU2020290484A1 (en) 2021-12-23

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