JP7275044B2 - 慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品 - Google Patents

慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品 Download PDF

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JP7275044B2
JP7275044B2 JP2019556864A JP2019556864A JP7275044B2 JP 7275044 B2 JP7275044 B2 JP 7275044B2 JP 2019556864 A JP2019556864 A JP 2019556864A JP 2019556864 A JP2019556864 A JP 2019556864A JP 7275044 B2 JP7275044 B2 JP 7275044B2
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immunoglobulin
immunoglobulin product
product
treatment
use according
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JP2020517636A5 (https=
JP2020517636A (ja
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オーレル・ミールケ
ジョン－フィリップ・ラヴォ
ビリー・ダーン
マイケル・トートリッチ
オトマール・ツェンカー
イーフォ・ファン・スカイク
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CSL Behring AG
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ZLB Bioplasma AG
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Priority claimed from PCT/EP2018/060158 external-priority patent/WO2018193078A1/en
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    • 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
    • A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2019556864A 2017-04-21 2018-04-20 慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品 Active JP7275044B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023075372A JP7621411B2 (ja) 2017-04-21 2023-05-01 慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201762488219P 2017-04-21 2017-04-21
US62/488,219 2017-04-21
EP17177134 2017-06-21
EP17177134.8 2017-06-21
US201762571812P 2017-10-13 2017-10-13
US62/571,812 2017-10-13
PCT/EP2018/060158 WO2018193078A1 (en) 2017-04-21 2018-04-20 Immunoglobulin products for use in the treatment of chronic inflammatory demyelinating polyneuropathy

Related Child Applications (1)

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JP2023075372A Division JP7621411B2 (ja) 2017-04-21 2023-05-01 慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品

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JP2020517636A JP2020517636A (ja) 2020-06-18
JP2020517636A5 JP2020517636A5 (https=) 2021-05-27
JP7275044B2 true JP7275044B2 (ja) 2023-05-17

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JP2019556864A Active JP7275044B2 (ja) 2017-04-21 2018-04-20 慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品
JP2023075372A Active JP7621411B2 (ja) 2017-04-21 2023-05-01 慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品

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JP2023075372A Active JP7621411B2 (ja) 2017-04-21 2023-05-01 慢性炎症性脱髄性多発神経炎の治療における使用のための免疫グロブリン製品

Country Status (6)

Country Link
US (1) US20200055922A1 (https=)
EP (1) EP3612221A1 (https=)
JP (2) JP7275044B2 (https=)
CN (1) CN110831627A (https=)
AU (2) AU2018253931A1 (https=)
CA (1) CA3060169A1 (https=)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011515395A (ja) 2008-03-17 2011-05-19 バクスター・ヘルスケア・ソシエテ・アノニム 免疫グロブリンおよびヒアルロニダーゼを皮下投与するための組み合わせおよび方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2012003282A (es) * 2009-09-17 2012-04-30 Baxter Healthcare Sa Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso.
JP2013523801A (ja) * 2010-04-08 2013-06-17 ウニヴェルズィテーツシュピタール バーゼル 免疫再構築症候群（ｉｒｉｓ）の処置及び予防における使用のための血漿由来免疫グロブリン
AU2010202125B1 (en) * 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
FR2962650B1 (fr) * 2010-07-19 2013-04-05 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
WO2019224304A1 (en) * 2018-05-23 2019-11-28 Csl Behring Ag Treatment of cidp

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011515395A (ja) 2008-03-17 2011-05-19 バクスター・ヘルスケア・ソシエテ・アノニム 免疫グロブリンおよびヒアルロニダーゼを皮下投与するための組み合わせおよび方法

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
ClinicalTraials.gov, U.S. National Institutes of Health, "A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)", NCT02549170, First Posted:2015.09.15, [retrieved on 2022.11.09], retrieved from the internet: <URL: https://clinicaltrials.gov/ct2/show/NCT02549170>
Eur. J. Neurology, 2013, Vol.20, pp.836-842
Eur. J. Neurology, 2016.12.21, Vol.24, No.2, pp.412-418
J. Peripheral Nervous System, 2016, Vol.21, No.2, pp.114-116
ｐＨ４処理酸性人免疫グロブリン（皮下注射）申請資料概要, CSLベーリング株式会社, 独立行政法人医薬品医療機器総合機構ホームページ, 2013.09.27, [retrieved on 2022.01.11], retrieved from the internet <URL; https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/6343439>
Trials, 2016, Vol.17, No.1, Article No.345, pp.1-15

Also Published As

Publication number Publication date
JP7621411B2 (ja) 2025-01-24
US20200055922A1 (en) 2020-02-20
EP3612221A1 (en) 2020-02-26
AU2025202358A1 (en) 2025-04-24
CA3060169A1 (en) 2018-10-25
JP2020517636A (ja) 2020-06-18
CN110831627A (zh) 2020-02-21
AU2018253931A1 (en) 2019-11-21
JP2023099143A (ja) 2023-07-11

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