JP2023501155A - クリザンリズマブ含有抗体製剤 - Google Patents

クリザンリズマブ含有抗体製剤 Download PDF

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Publication number
JP2023501155A
JP2023501155A JP2022524914A JP2022524914A JP2023501155A JP 2023501155 A JP2023501155 A JP 2023501155A JP 2022524914 A JP2022524914 A JP 2022524914A JP 2022524914 A JP2022524914 A JP 2022524914A JP 2023501155 A JP2023501155 A JP 2023501155A
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JP
Japan
Prior art keywords
pharmaceutical composition
composition according
clizanlizumab
concentration
suitably
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2022524914A
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English (en)
Japanese (ja)
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JP2023501155A5 (enExample
Inventor
ビッケル，ファビアン
ボード，リナ
チェリウス，ダーク
グリオード，フランソワ
ヒルバート，キャロライン
クレーナー，フリーダー
シグ，ユルゲン
ポール，ラジャセカール
アンコ，マヤ
イエレンコ，アリョーシャ
Original Assignee
ノバルティス アーゲー
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Application filed by ノバルティス アーゲー filed Critical ノバルティス アーゲー
Publication of JP2023501155A publication Critical patent/JP2023501155A/ja
Publication of JP2023501155A5 publication Critical patent/JP2023501155A5/ja
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • 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
    • C07K16/2851—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • C07K16/2854—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • 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
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2022524914A 2019-10-30 2020-10-29 クリザンリズマブ含有抗体製剤 Pending JP2023501155A (ja)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201962927720P 2019-10-30 2019-10-30
US201962927716P 2019-10-30 2019-10-30
US62/927,716 2019-10-30
US62/927,720 2019-10-30
US201962933692P 2019-11-11 2019-11-11
US62/933,692 2019-11-11
US201962936269P 2019-11-15 2019-11-15
US62/936,269 2019-11-15
PCT/US2020/057868 WO2021087050A1 (en) 2019-10-30 2020-10-29 Crizanlizumab containing antibody formulation

Publications (2)

Publication Number Publication Date
JP2023501155A true JP2023501155A (ja) 2023-01-18
JP2023501155A5 JP2023501155A5 (enExample) 2023-11-07

Family

ID=73544317

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2022524914A Pending JP2023501155A (ja) 2019-10-30 2020-10-29 クリザンリズマブ含有抗体製剤

Country Status (19)

Country Link
US (1) US20220378912A1 (enExample)
EP (1) EP4051236A1 (enExample)
JP (1) JP2023501155A (enExample)
KR (1) KR20220092917A (enExample)
CN (1) CN114828826A (enExample)
AU (1) AU2020373017B2 (enExample)
BR (1) BR112022008097A2 (enExample)
CA (1) CA3158921A1 (enExample)
CL (1) CL2022001085A1 (enExample)
CO (1) CO2022005207A2 (enExample)
EC (1) ECSP22033601A (enExample)
IL (1) IL292403A (enExample)
JO (1) JOP20220097A1 (enExample)
MX (1) MX2022005044A (enExample)
MY (1) MY209141A (enExample)
PE (1) PE20221276A1 (enExample)
PH (1) PH12022551041A1 (enExample)
TW (1) TWI893018B (enExample)
WO (1) WO2021087050A1 (enExample)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018083645A1 (en) * 2016-11-03 2018-05-11 Novartis Ag Treatment regimens

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE041957T2 (hu) 2006-12-01 2019-06-28 Novartis Ag Anti-P-szelektin antitestek és eljárások azok alkalmazására gyulladásos betegségek kezelésére
US10646569B2 (en) * 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
CA3092931A1 (en) * 2018-03-08 2019-09-12 Novartis Ag Use of an anti-p-selectin antibody

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018083645A1 (en) * 2016-11-03 2018-05-11 Novartis Ag Treatment regimens

Also Published As

Publication number Publication date
IL292403A (en) 2022-06-01
TW202128221A (zh) 2021-08-01
WO2021087050A1 (en) 2021-05-06
CN114828826A (zh) 2022-07-29
MX2022005044A (es) 2022-05-16
ECSP22033601A (es) 2022-05-31
CA3158921A1 (en) 2021-05-06
AU2020373017B2 (en) 2024-06-06
PH12022551041A1 (en) 2023-04-24
CO2022005207A2 (es) 2022-05-10
BR112022008097A2 (pt) 2022-08-02
KR20220092917A (ko) 2022-07-04
JOP20220097A1 (ar) 2023-01-30
EP4051236A1 (en) 2022-09-07
US20220378912A1 (en) 2022-12-01
CL2022001085A1 (es) 2023-02-03
AU2020373017A1 (en) 2022-05-19
MY209141A (en) 2025-06-24
TWI893018B (zh) 2025-08-11
PE20221276A1 (es) 2022-09-05

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