ES2980137T3 - Una composición farmacéutica para su uso en el tratamiento o la prevención de una enfermedad relacionada con C5 - Google Patents

Una composición farmacéutica para su uso en el tratamiento o la prevención de una enfermedad relacionada con C5 Download PDF

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Publication number
ES2980137T3
ES2980137T3 ES19755447T ES19755447T ES2980137T3 ES 2980137 T3 ES2980137 T3 ES 2980137T3 ES 19755447 T ES19755447 T ES 19755447T ES 19755447 T ES19755447 T ES 19755447T ES 2980137 T3 ES2980137 T3 ES 2980137T3
Authority
ES
Spain
Prior art keywords
antibody
dose
days
administered
pharmaceutical composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES19755447T
Other languages
English (en)
Spanish (es)
Inventor
Kenji Shinomiya
Keisuke Gotanda
Jun-Ichi Nishimura
Erica Winter
Joy C Hsu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Chugai Pharmaceutical Co Ltd
The University of Osaka
Original Assignee
F Hoffmann La Roche AG
Chugai Pharmaceutical Co Ltd
Osaka University NUC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Chugai Pharmaceutical Co Ltd, Osaka University NUC filed Critical F Hoffmann La Roche AG
Application granted granted Critical
Publication of ES2980137T3 publication Critical patent/ES2980137T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61P7/06—Antianaemics
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Transplantation (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ES19755447T 2018-08-01 2019-08-01 Una composición farmacéutica para su uso en el tratamiento o la prevención de una enfermedad relacionada con C5 Active ES2980137T3 (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201862713211P 2018-08-01 2018-08-01
US201862764952P 2018-08-17 2018-08-17
US201862760204P 2018-11-13 2018-11-13
PCT/JP2019/030283 WO2020027279A1 (en) 2018-08-01 2019-08-01 A pharmaceutical composition for use in the treatment or prevention of a c5-related disease and a method for treating or preventing a c5-related disease

Publications (1)

Publication Number Publication Date
ES2980137T3 true ES2980137T3 (es) 2024-09-30

Family

ID=67660420

Family Applications (1)

Application Number Title Priority Date Filing Date
ES19755447T Active ES2980137T3 (es) 2018-08-01 2019-08-01 Una composición farmacéutica para su uso en el tratamiento o la prevención de una enfermedad relacionada con C5

Country Status (23)

Country Link
US (1) US20210301004A1 (enExample)
EP (2) EP4445913A3 (enExample)
JP (4) JP6672516B2 (enExample)
KR (5) KR20200033225A (enExample)
CN (1) CN112512563A (enExample)
AU (2) AU2019315213B2 (enExample)
BR (1) BR112021001655A2 (enExample)
CA (1) CA3107618A1 (enExample)
CR (1) CR20210103A (enExample)
DE (1) DE112019003835T5 (enExample)
ES (1) ES2980137T3 (enExample)
HR (1) HRP20240823T1 (enExample)
HU (1) HUE067057T2 (enExample)
IL (2) IL324626A (enExample)
MX (2) MX2021000516A (enExample)
MY (1) MY210523A (enExample)
PH (1) PH12021550226A1 (enExample)
PL (1) PL3829628T3 (enExample)
RS (1) RS65630B1 (enExample)
SG (1) SG10202002898RA (enExample)
SM (1) SMT202400271T1 (enExample)
TW (2) TWI701041B (enExample)
WO (1) WO2020027279A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4793360A2 (en) 2006-03-31 2026-08-19 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
EP3127921A1 (en) 2007-09-26 2017-02-08 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substition in cdr
TW201920257A (zh) 2008-04-11 2019-06-01 日商中外製藥股份有限公司 重複結合複數個抗原的抗原結合分子
TWI654203B (zh) 2010-11-30 2019-03-21 Chugai Seiyaku Kabushiki Kaisha 具有鈣依存性的抗原結合能力之抗體
MX2017005774A (es) 2014-12-19 2017-07-28 Chugai Pharmaceutical Co Ltd Anticuerpos antimiostatina, polipeptidos que contienen regiones fc variantes, y metodos de uso.
EA201791366A1 (ru) 2014-12-19 2018-02-28 Чугаи Сейяку Кабусики Кайся Антитела к c5 и способы их применения
CN114773469B (zh) 2015-02-05 2025-12-19 中外制药株式会社 包含离子浓度依赖性的抗原结合结构域的抗体，fc区变体，il-8-结合抗体及其应用
EP3394098A4 (en) 2015-12-25 2019-11-13 Chugai Seiyaku Kabushiki Kaisha ANTI-MYOSTATIN ANTIBODIES AND METHOD OF USE
CN116271014A (zh) 2016-08-05 2023-06-23 中外制药株式会社 用于预防或治疗il-8相关疾病的组合物

Family Cites Families (31)

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IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
JP3101690B2 (ja) 1987-03-18 2000-10-23 エス・ビィ・２・インコーポレイテッド 変性抗体の、または変性抗体に関する改良
EP0590058B1 (en) 1991-06-14 2003-11-26 Genentech, Inc. HUMANIZED Heregulin ANTIBODy
AU691811B2 (en) 1993-06-16 1998-05-28 Celltech Therapeutics Limited Antibodies
US6074642A (en) 1994-05-02 2000-06-13 Alexion Pharmaceuticals, Inc. Use of antibodies specific to human complement component C5 for the treatment of glomerulonephritis
US6194551B1 (en) 1998-04-02 2001-02-27 Genentech, Inc. Polypeptide variants
CA2323757C (en) 1998-04-02 2011-08-02 Genentech, Inc. Antibody variants and fragments thereof
HUP0104865A3 (en) 1999-01-15 2004-07-28 Genentech Inc Polypeptide variants with altered effector function
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MXPA04001301A (es) 2001-08-17 2004-07-08 Tanox Inc Inhibidores de la ruta del complemento que se unen a c5 y c5a son evitar la formacion de c5b.
ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
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HUE035898T2 (en) 2002-12-16 2018-05-28 Genentech Inc Immunoglobulin variants and their applications
US20070116710A1 (en) 2004-02-03 2007-05-24 Leonard Bell Methods of treating hemolytic anemia
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WO2005100402A1 (en) 2004-04-13 2005-10-27 F.Hoffmann-La Roche Ag Anti-p-selectin antibodies
TWI309240B (en) 2004-09-17 2009-05-01 Hoffmann La Roche Anti-ox40l antibodies
HUE066795T2 (hu) 2006-03-15 2024-09-28 Alexion Pharma Inc Paroxysmalis nocturnalis haemoglobinuriában szenvedõ betegek kezelése egy komplement inhibitorral
TW201920257A (zh) 2008-04-11 2019-06-01 日商中外製藥股份有限公司 重複結合複數個抗原的抗原結合分子
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
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EA201791366A1 (ru) * 2014-12-19 2018-02-28 Чугаи Сейяку Кабусики Кайся Антитела к c5 и способы их применения
TWI759261B (zh) * 2015-02-27 2022-04-01 日商中外製藥股份有限公司 Ｉｌ－６受體抗體用於製備醫藥組成物的用途
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Also Published As

Publication number Publication date
SG10202002898RA (en) 2020-05-28
KR20210037743A (ko) 2021-04-06
EP3829628A1 (en) 2021-06-09
DE112019003835T5 (de) 2021-05-27
IL280475B2 (en) 2026-04-01
KR20200033348A (ko) 2020-03-27
KR20200033225A (ko) 2020-03-27
JP2020019769A (ja) 2020-02-06
HRP20240823T1 (hr) 2024-09-27
EP4445913A2 (en) 2024-10-16
TWI701041B (zh) 2020-08-11
EP3829628C0 (en) 2024-05-15
JP6672533B1 (ja) 2020-03-25
IL324626A (en) 2026-01-01
AU2019315213B2 (en) 2024-05-02
TW202019467A (zh) 2020-06-01
BR112021001655A2 (pt) 2021-05-04
KR20210038697A (ko) 2021-04-07
SMT202400271T1 (it) 2024-07-09
TW202024128A (zh) 2020-07-01
EP3829628B1 (en) 2024-05-15
JP2020079331A (ja) 2020-05-28
CR20210103A (es) 2021-03-22
JP2025065367A (ja) 2025-04-17
US20210301004A1 (en) 2021-09-30
JP2020073608A (ja) 2020-05-14
IL280475B1 (en) 2025-12-01
MY210523A (en) 2025-09-29
HUE067057T2 (hu) 2024-09-28
PH12021550226A1 (en) 2021-10-11
JP6672516B2 (ja) 2020-03-25
TWI704157B (zh) 2020-09-11
IL280475A (en) 2021-03-01
CA3107618A1 (en) 2020-02-06
CN112512563A (zh) 2021-03-16
AU2024205486A1 (en) 2024-08-22
WO2020027279A1 (en) 2020-02-06
PL3829628T3 (pl) 2024-08-19
MX2021000516A (es) 2021-04-12
MX2025010400A (es) 2025-10-01
KR20240115904A (ko) 2024-07-26
EP4445913A3 (en) 2025-01-01
RS65630B1 (sr) 2024-07-31
AU2019315213A1 (en) 2021-03-25

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