JP2024522855A - 第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用 - Google Patents

第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用 Download PDF

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Publication number
JP2024522855A
JP2024522855A JP2023579138A JP2023579138A JP2024522855A JP 2024522855 A JP2024522855 A JP 2024522855A JP 2023579138 A JP2023579138 A JP 2023579138A JP 2023579138 A JP2023579138 A JP 2023579138A JP 2024522855 A JP2024522855 A JP 2024522855A
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Japan
Prior art keywords
pharmaceutical composition
arginine
polysorbate
histidine
sucrose
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Pending
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JP2023579138A
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English (en)
Japanese (ja)
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JP2024522855A5 (enExample
Inventor
タイラー・カーレッジ
ランドル・モールディン
ルブナ・ムザーラック・タジ
ティモシー・アール・マッコイ
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バイオベラティブ セラピューティクス インコーポレイテッド
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Publication of JP2024522855A publication Critical patent/JP2024522855A/ja
Publication of JP2024522855A5 publication Critical patent/JP2024522855A5/ja
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012—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
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2023579138A 2021-06-23 2022-06-23 第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用 Pending JP2024522855A (ja)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US202163214246P 2021-06-23 2021-06-23
US202163214245P 2021-06-23 2021-06-23
US63/214,246 2021-06-23
US63/214,245 2021-06-23
US202163214752P 2021-06-24 2021-06-24
US63/214,752 2021-06-24
US202163231909P 2021-08-11 2021-08-11
US63/231,909 2021-08-11
PCT/US2022/034747 WO2022271962A1 (en) 2021-06-23 2022-06-23 Formulations of factor viii chimeric proteins and uses thereof

Publications (2)

Publication Number Publication Date
JP2024522855A true JP2024522855A (ja) 2024-06-21
JP2024522855A5 JP2024522855A5 (enExample) 2025-06-30

Family

ID=82656587

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023579138A Pending JP2024522855A (ja) 2021-06-23 2022-06-23 第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用

Country Status (12)

Country Link
US (1) US20240287158A1 (enExample)
EP (1) EP4358938A1 (enExample)
JP (1) JP2024522855A (enExample)
KR (1) KR20240024949A (enExample)
AU (1) AU2022298798A1 (enExample)
BR (1) BR112023026782A2 (enExample)
CA (1) CA3220564A1 (enExample)
CO (1) CO2023017358A2 (enExample)
IL (1) IL309309A (enExample)
MX (1) MX2023015238A (enExample)
TW (1) TW202317178A (enExample)
WO (1) WO2022271962A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA201691111A1 (ru) 2014-01-10 2017-01-30 Байоджен Ма Инк. Химерные белки фактора viii и их применение
EP4489771A2 (en) * 2022-03-08 2025-01-15 Bioverativ Therapeutics Inc. Methods of treating hemophilia a

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE198277T1 (de) * 1992-10-02 2001-01-15 Genetics Inst Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
EP2385825B1 (en) * 2008-11-07 2018-10-10 University of Connecticut Factor viii formulations
ES2770501T3 (es) 2012-07-11 2020-07-01 Bioverativ Therapeutics Inc Complejo del factor VIII con XTEN y proteína del factor de Von Willebrand y sus usos
EA201691111A1 (ru) 2014-01-10 2017-01-30 Байоджен Ма Инк. Химерные белки фактора viii и их применение
KR102914074B1 (ko) 2018-05-18 2026-01-16 바이오버라티브 테라퓨틱스 인크. A형 혈우병의 치료 방법
AU2020298233A1 (en) * 2019-06-19 2022-01-20 Bioverativ Therapeutics Inc. Recombinant factor VIII-Fc for treating hemophilia and low bone mineral density
WO2021032646A1 (en) * 2019-08-16 2021-02-25 Octapharma Ag Stabilizing buffer for factor viii and vwf
EP4489771A2 (en) * 2022-03-08 2025-01-15 Bioverativ Therapeutics Inc. Methods of treating hemophilia a

Also Published As

Publication number Publication date
US20240287158A1 (en) 2024-08-29
CA3220564A1 (en) 2022-12-29
TW202317178A (zh) 2023-05-01
CO2023017358A2 (es) 2024-01-15
IL309309A (en) 2024-02-01
EP4358938A1 (en) 2024-05-01
KR20240024949A (ko) 2024-02-26
BR112023026782A2 (pt) 2024-03-12
AU2022298798A1 (en) 2024-02-08
MX2023015238A (es) 2024-03-08
WO2022271962A1 (en) 2022-12-29

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