JP7518764B2 - 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与 - Google Patents

発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与 Download PDF

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JP7518764B2
JP7518764B2 JP2020521452A JP2020521452A JP7518764B2 JP 7518764 B2 JP7518764 B2 JP 7518764B2 JP 2020521452 A JP2020521452 A JP 2020521452A JP 2020521452 A JP2020521452 A JP 2020521452A JP 7518764 B2 JP7518764 B2 JP 7518764B2
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JP2021501134A5 (enExample
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ロリ シャフナー,
スコット ティー. ロッティングハウス,
ラジェンドラ プラダーン,
アンドリュー ダモコシュ,
シャン ガオ,
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アレクシオン ファーマシューティカルズ, インコーポレイテッド
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/468Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Dermatology (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)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2020521452A 2017-10-26 2018-10-26 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与 Active JP7518764B2 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2022171473A JP2022186933A (ja) 2017-10-26 2022-10-26 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2025125710A JP2025146943A (ja) 2017-10-26 2025-07-28 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2025125711A JP2025146944A (ja) 2017-10-26 2025-07-28 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201762577244P 2017-10-26 2017-10-26
US62/577,244 2017-10-26
US201862643056P 2018-03-14 2018-03-14
US62/643,056 2018-03-14
US201862643608P 2018-03-15 2018-03-15
US62/643,608 2018-03-15
US201862662503P 2018-04-25 2018-04-25
US62/662,503 2018-04-25
US201862685505P 2018-06-15 2018-06-15
US201862685425P 2018-06-15 2018-06-15
US62/685,505 2018-06-15
US62/685,425 2018-06-15
PCT/US2018/057760 WO2019084438A1 (en) 2017-10-26 2018-10-26 ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)

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JP2022171473A Division JP2022186933A (ja) 2017-10-26 2022-10-26 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与

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JP2021501134A JP2021501134A (ja) 2021-01-14
JP2021501134A5 JP2021501134A5 (enExample) 2021-11-04
JP7518764B2 true JP7518764B2 (ja) 2024-07-18

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JP2020521452A Active JP7518764B2 (ja) 2017-10-26 2018-10-26 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2022171473A Withdrawn JP2022186933A (ja) 2017-10-26 2022-10-26 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2025125710A Pending JP2025146943A (ja) 2017-10-26 2025-07-28 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2025125711A Pending JP2025146944A (ja) 2017-10-26 2025-07-28 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与

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JP2022171473A Withdrawn JP2022186933A (ja) 2017-10-26 2022-10-26 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2025125710A Pending JP2025146943A (ja) 2017-10-26 2025-07-28 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2025125711A Pending JP2025146944A (ja) 2017-10-26 2025-07-28 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与

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US (3) US12128101B2 (enExample)
EP (1) EP3700928A1 (enExample)
JP (4) JP7518764B2 (enExample)
KR (2) KR20240162603A (enExample)
CN (2) CN111868081A (enExample)
AU (1) AU2018354404B2 (enExample)
BR (1) BR112020008182A2 (enExample)
CA (1) CA3080187A1 (enExample)
CO (1) CO2020004838A2 (enExample)
MX (2) MX2020004284A (enExample)
WO (1) WO2019084438A1 (enExample)

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JOP20220030A1 (ar) * 2019-08-16 2023-01-30 Regeneron Pharma صيغ مضادة لـ c5 عالية التركيز
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