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 (https=
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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Application filed by 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 filed Critical 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, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • 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

Landscapes

  • 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)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (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 (https=) 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 (https=)
EP (1) EP2968498A4 (https=)
JP (6) JP6387392B2 (https=)
AR (1) AR095527A1 (https=)
AU (4) AU2014228938B2 (https=)
CA (1) CA2899089C (https=)
CL (1) CL2015002719A1 (https=)
EA (1) EA037906B1 (https=)
HK (1) HK1220619A1 (https=)
PH (1) PH12015501854A1 (https=)
SG (3) SG11201505926VA (https=)
TW (4) TWI683666B (https=)
UY (1) UY35463A (https=)
WO (1) WO2014144549A1 (https=)

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UA126265C2 (uk) 2010-07-09 2022-09-14 Байовератів Терапьютікс Інк. Поліпептид фактора іх і спосіб його застосування
EP3970737A1 (en) * 2012-01-12 2022-03-23 Bioverativ Therapeutics Inc. Reducing immunogenicity against factor viii in individuals undergoing factor viii therapy
TWI750197B (zh) * 2012-09-25 2021-12-21 美商百歐維拉提夫治療公司 Ｆｉｘ多肽的應用
AR095527A1 (es) 2013-03-15 2015-10-21 Biogen Idec Inc Formulaciones de polipéptido fc-factor ix
EA202092926A3 (ru) 2014-03-24 2021-10-29 Биовератив Терапьютикс Инк. Лиофилизированные составы, содержащие фактор ix
BR112018002150A2 (pt) 2015-08-03 2018-09-18 Bioverativ Therapeutics Inc proteínas de fusão do fator ix e métodos de fabricação e uso das mesmas
IL319473A (en) * 2016-12-02 2025-05-01 Bioverativ Therapeutics Inc Methods for treating hemophilic arthritis using chimeric blood clotting factors
CN110520149A (zh) 2016-12-02 2019-11-29 比奥维拉迪维治疗股份有限公司 诱导对凝血因子的免疫耐受性的方法
BR112020022164A2 (pt) 2018-05-18 2021-02-02 Bioverativ Therapeutics Inc. métodos de tratamento de hemofilia a

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