JP6387392B2 - 第ｉｘ因子ポリペプチド製剤 - Google Patents

第ｉｘ因子ポリペプチド製剤 Download PDF

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Publication number
JP6387392B2
JP6387392B2 JP2016502963A JP2016502963A JP6387392B2 JP 6387392 B2 JP6387392 B2 JP 6387392B2 JP 2016502963 A JP2016502963 A JP 2016502963A JP 2016502963 A JP2016502963 A JP 2016502963A JP 6387392 B2 JP6387392 B2 JP 6387392B2
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Prior art keywords
polysorbate
pharmaceutical composition
polypeptide
item
mannitol
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Japanese (ja)
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JP2016519670A (ja
JP2016519670A5 (enExample
Inventor
マーク ブレーダー，
マーク ブレーダー，
Original Assignee
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
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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Classifications

    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hospice & Palliative Care (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)
JP2016502963A 2013-03-15 2014-03-14 第ｉｘ因子ポリペプチド製剤 Active JP6387392B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361794874P 2013-03-15 2013-03-15
US61/794,874 2013-03-15
PCT/US2014/029010 WO2014144549A1 (en) 2013-03-15 2014-03-14 Factor ix polypeptide formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2018119813A Division JP6800916B2 (ja) 2013-03-15 2018-06-25 第ｉｘ因子ポリペプチド製剤

Publications (3)

Publication Number Publication Date
JP2016519670A JP2016519670A (ja) 2016-07-07
JP2016519670A5 JP2016519670A5 (enExample) 2017-04-20
JP6387392B2 true JP6387392B2 (ja) 2018-09-05

Family

ID=51537733

Family Applications (6)

Application Number Title Priority Date Filing Date
JP2016502963A Active JP6387392B2 (ja) 2013-03-15 2014-03-14 第ｉｘ因子ポリペプチド製剤
JP2018119813A Active JP6800916B2 (ja) 2013-03-15 2018-06-25 第ｉｘ因子ポリペプチド製剤
JP2019188574A Active JP7591866B2 (ja) 2013-03-15 2019-10-15 第ｉｘ因子ポリペプチド製剤
JP2021143100A Withdrawn JP2021183645A (ja) 2013-03-15 2021-09-02 第ｉｘ因子ポリペプチド製剤
JP2023147524A Active JP7741145B2 (ja) 2013-03-15 2023-09-12 第ｉｘ因子ポリペプチド製剤
JP2025145844A Pending JP2025168477A (ja) 2013-03-15 2025-09-03 第ｉｘ因子ポリペプチド製剤

Family Applications After (5)

Application Number Title Priority Date Filing Date
JP2018119813A Active JP6800916B2 (ja) 2013-03-15 2018-06-25 第ｉｘ因子ポリペプチド製剤
JP2019188574A Active JP7591866B2 (ja) 2013-03-15 2019-10-15 第ｉｘ因子ポリペプチド製剤
JP2021143100A Withdrawn JP2021183645A (ja) 2013-03-15 2021-09-02 第ｉｘ因子ポリペプチド製剤
JP2023147524A Active JP7741145B2 (ja) 2013-03-15 2023-09-12 第ｉｘ因子ポリペプチド製剤
JP2025145844A Pending JP2025168477A (ja) 2013-03-15 2025-09-03 第ｉｘ因子ポリペプチド製剤

Country Status (14)

Country Link
US (3) US10588949B2 (enExample)
EP (1) EP2968498A4 (enExample)
JP (6) JP6387392B2 (enExample)
AR (1) AR095527A1 (enExample)
AU (4) AU2014228938B2 (enExample)
CA (1) CA2899089C (enExample)
CL (1) CL2015002719A1 (enExample)
EA (1) EA037906B1 (enExample)
HK (1) HK1220619A1 (enExample)
PH (1) PH12015501854A1 (enExample)
SG (3) SG11201505926VA (enExample)
TW (4) TWI828269B (enExample)
UY (1) UY35463A (enExample)
WO (1) WO2014144549A1 (enExample)

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WO2014052490A1 (en) 2012-09-25 2014-04-03 Biogen Idec Ma Inc. Methods of using fix polypeptides
SG11201505926VA (en) 2013-03-15 2015-09-29 Biogen Ma Inc Factor ix polypeptide formulations
EA201691111A1 (ru) 2014-01-10 2017-01-30 Байоджен Ма Инк. Химерные белки фактора viii и их применение
EA202092926A3 (ru) 2014-03-24 2021-10-29 Биовератив Терапьютикс Инк. Лиофилизированные составы, содержащие фактор ix
UA126016C2 (uk) 2015-08-03 2022-08-03 Біовератів Терапеутікс Інк. Злитий білок фактора іх
CA3044838A1 (en) 2016-12-02 2018-06-07 Bioverativ Therapeutics Inc. Methods of inducing immune tolerance to clotting factors
KR20190090827A (ko) * 2016-12-02 2019-08-02 바이오버라티브 테라퓨틱스 인크. 키메라 응고 인자를 사용해 혈우병성 관절증을 치료하는 방법
KR102914074B1 (ko) 2018-05-18 2026-01-16 바이오버라티브 테라퓨틱스 인크. A형 혈우병의 치료 방법

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