CN102625712B - 用于因子xa抑制剂的解毒剂的单位剂量制剂及其使用方法 - Google Patents

用于因子xa抑制剂的解毒剂的单位剂量制剂及其使用方法 Download PDF

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Publication number
CN102625712B
CN102625712B CN201080040105.XA CN201080040105A CN102625712B CN 102625712 B CN102625712 B CN 102625712B CN 201080040105 A CN201080040105 A CN 201080040105A CN 102625712 B CN102625712 B CN 102625712B
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fxa
antidote
inhibitor
preparation
factor
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CN102625712A (zh
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U.辛哈
卢根民
A.哈特查理拉哈
S.J.霍伦巴克
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Portola Pharmaceuticals LLC
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    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6432—Coagulation factor Xa (3.4.21.6)
    • 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)
    • C12Y304/21006—Coagulation factor Xa (3.4.21.6)

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
CN201080040105.XA 2009-07-15 2010-07-14 用于因子xa抑制剂的解毒剂的单位剂量制剂及其使用方法 Active CN102625712B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US22588709P 2009-07-15 2009-07-15
US61/225,887 2009-07-15
PCT/US2010/042015 WO2011008885A1 (en) 2009-07-15 2010-07-14 Unit dose formulation of antidotes for factor xa inhibitors and methods of using the same

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CN102625712A CN102625712A (zh) 2012-08-01
CN102625712B true CN102625712B (zh) 2017-07-25

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US (8) US9056106B2 (enExample)
EP (1) EP2453910B1 (enExample)
JP (2) JP6163304B2 (enExample)
CN (1) CN102625712B (enExample)
CA (1) CA2767858C (enExample)
ES (1) ES2605801T3 (enExample)
PT (1) PT2453910T (enExample)
WO (1) WO2011008885A1 (enExample)

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EP2016072B1 (en) 2006-05-05 2014-07-16 Millennium Pharmaceuticals, Inc. Factor xa inhibitors
PT3078743T (pt) 2007-09-28 2020-07-15 Portola Pharm Inc Antídotos para inibidores do fator xa e métodos de utilização dos mesmos
EP3604510B1 (en) * 2009-03-30 2025-03-26 Alexion Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
WO2011008885A1 (en) 2009-07-15 2011-01-20 Portola Pharmaceuticals, Inc. Unit dose formulation of antidotes for factor xa inhibitors and methods of using the same
WO2011075602A1 (en) * 2009-12-17 2011-06-23 Millennium Pharmaceuticals, Inc. Methods of preparing factor xa inhibitors and salts thereof
JP5796872B2 (ja) * 2009-12-17 2015-10-21 ミレニアム ファーマシューティカルズ， インコーポレイテッドＭｉｌｌｅｎｎｉｕｍ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 第Ｘａ因子阻害剤の結晶性塩
US20130230901A1 (en) * 2012-02-14 2013-09-05 Portola Pharmaceuticals, Inc. Process for making recombinant antidote to factor xa inhibitor
WO2013123248A1 (en) 2012-02-16 2013-08-22 Portola Pharmaceuticals, Inc. MODULATION OF FACTOR Xa INHIBITOR MEDIATED BLOOD LOSS BY PARTIAL AND TRANSIENT ADMINISTRATION OF ANTIDOTE
AU2013293573B2 (en) * 2012-07-25 2016-10-27 Catalyst Biosciences, Inc. Modified Factor X polypeptides and uses thereof
FR3000895B1 (fr) * 2013-01-11 2017-02-24 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Sa Utilisation d'antidotes d'inhibiteurs de la coagulation indiques dans la prevention ou le traitement de pathologies thromboemboliques
SG10201705189XA (en) * 2013-01-24 2017-07-28 Portola Pharm Inc INHIBITION OF TISSUE FACTOR PATHWAY INHIBITOR WITH FACTOR Xa DERIVATIVES
ES2761730T3 (es) * 2013-01-31 2020-05-20 Pfizer Composiciones y procedimientos para contrarrestar la inhibición del factor Xa
KR101988705B1 (ko) 2013-09-24 2019-06-12 화이자 인코포레이티드 재조합 인간 응고 인자 Xa 단백질의 이질적 집단을 포함하는 조성물
JP6629744B2 (ja) * 2013-11-01 2020-01-15 ザ・チルドレンズ・ホスピタル・オブ・フィラデルフィアＴｈｅ Ｃｈｉｌｄｒｅｎ’Ｓ Ｈｏｓｐｉｔａｌ Ｏｆ Ｐｈｉｌａｄｅｌｐｈｉａ 第Ｘａ因子の半減期を延ばす組成物および方法
AU2015208819B2 (en) * 2014-01-24 2020-01-23 Pfizer Inc. Compositions and methods for treating intracerebral hemorrhage
US9545383B2 (en) 2014-04-01 2017-01-17 Massachusetts Institute Of Technology Blood clotting control
WO2015183085A1 (en) 2014-05-26 2015-12-03 Academisch Ziekenhuis Leiden Prohemostatic proteins for the treatment of bleeding
US10676731B2 (en) 2014-08-19 2020-06-09 The Children's Hospital Of Philadelphia Compositions and methods for modulating factor IX function
AU2015305413B2 (en) * 2014-08-20 2020-09-24 Alexion Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
ES2884119T3 (es) 2016-02-24 2021-12-10 Alexion Pharma Inc Fórmulas liofilizadas para antídoto contra el factor Xa
TW201802121A (zh) 2016-05-25 2018-01-16 諾華公司 抗因子XI/XIa抗體之逆轉結合劑及其用途
EP3472314B1 (en) * 2016-06-17 2021-05-05 Alexion Pharmaceuticals, Inc. Preparation of factor xa derivatives
AU2017383232B2 (en) 2016-12-23 2024-09-12 Novartis Ag Factor XI antibodies and methods of use
JP7641903B2 (ja) * 2019-02-07 2025-03-07 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 頭蓋内出血の治療方法及び効果の評価方法
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