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
University of Osaka NUC
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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], 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, 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)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Diabetes (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)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (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 (OSRAM)
EP (2) EP4445913A3 (OSRAM)
JP (4) JP6672516B2 (OSRAM)
KR (5) KR20200033348A (OSRAM)
CN (1) CN112512563A (OSRAM)
AU (2) AU2019315213B2 (OSRAM)
BR (1) BR112021001655A2 (OSRAM)
CA (1) CA3107618A1 (OSRAM)
CR (1) CR20210103A (OSRAM)
DE (1) DE112019003835T5 (OSRAM)
ES (1) ES2980137T3 (OSRAM)
HR (1) HRP20240823T1 (OSRAM)
HU (1) HUE067057T2 (OSRAM)
IL (1) IL280475B1 (OSRAM)
MX (2) MX2021000516A (OSRAM)
MY (1) MY210523A (OSRAM)
PH (1) PH12021550226A1 (OSRAM)
PL (1) PL3829628T3 (OSRAM)
RS (1) RS65630B1 (OSRAM)
SG (1) SG10202002898RA (OSRAM)
SM (1) SMT202400271T1 (OSRAM)
TW (2) TWI704157B (OSRAM)
WO (1) WO2020027279A1 (OSRAM)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2647846C (en) 2006-03-31 2016-06-21 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
PL2202245T3 (pl) 2007-09-26 2017-02-28 Chugai Seiyaku Kabushiki Kaisha Sposób modyfikowania punktu izoelektrycznego przeciwciała poprzez podstawienie aminokwasu w cdr
KR102269708B1 (ko) 2008-04-11 2021-06-25 추가이 세이야쿠 가부시키가이샤 복수 분자의 항원에 반복 결합하는 항원 결합 분자
EP4231014A3 (en) 2010-11-30 2024-08-14 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to plurality of antigen molecules repeatedly
JP6174782B2 (ja) 2014-12-19 2017-08-02 中外製薬株式会社 抗ｃ５抗体および使用方法
IL278014B2 (en) 2014-12-19 2023-10-01 Chugai Pharmaceutical Co Ltd Anti-myostatin antibodies, polypeptides containing variable FC regions and methods of use
EP3394098A4 (en) 2015-12-25 2019-11-13 Chugai Seiyaku Kabushiki Kaisha ANTI-MYOSTATIN ANTIBODIES AND METHODS OF USE
TWI831965B (zh) 2016-08-05 2024-02-11 日商中外製藥股份有限公司 Il-8相關疾病之治療用或預防用組成物

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
AU600575B2 (en) 1987-03-18 1990-08-16 Sb2, Inc. Altered antibodies
CA2103059C (en) 1991-06-14 2005-03-22 Paul J. Carter Method for making humanized antibodies
CA2163345A1 (en) 1993-06-16 1994-12-22 Susan Adrienne Morgan 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
EP1068241B1 (en) 1998-04-02 2007-10-10 Genentech, Inc. Antibody variants and fragments thereof
PL209786B1 (pl) 1999-01-15 2011-10-31 Genentech Inc Przeciwciało zawierające wariant regionu Fc ludzkiej IgG1, przeciwciało wiążące czynnik wzrostu śródbłonka naczyń oraz immunoadhezyna
US6737056B1 (en) 1999-01-15 2004-05-18 Genentech, Inc. Polypeptide variants with altered effector function
EP2113516B1 (en) 2000-10-10 2014-05-21 Genentech, Inc. Antibodies against C5 inhibiting type II endothelial cell activation
ATE360441T1 (de) 2001-08-17 2007-05-15 Tanox Inc Komplement-inhibitoren die an c5 und c5a binden ohne die bildung von c5b zu hemmen
ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
US7361740B2 (en) 2002-10-15 2008-04-22 Pdl Biopharma, Inc. Alteration of FcRn binding affinities or serum half-lives of antibodies by mutagenesis
WO2004056312A2 (en) 2002-12-16 2004-07-08 Genentech, Inc. Immunoglobulin variants and uses thereof
US20070116710A1 (en) 2004-02-03 2007-05-24 Leonard Bell Methods of treating hemolytic anemia
US20050169921A1 (en) 2004-02-03 2005-08-04 Leonard Bell Method of treating hemolytic disease
JP4633788B2 (ja) 2004-04-13 2011-02-16 エフ．ホフマン−ラ ロシュ アーゲー 抗ｐ−セレクチン抗体
TWI380996B (zh) 2004-09-17 2013-01-01 Hoffmann La Roche 抗ｏｘ４０ｌ抗體
EP3124029A1 (en) 2006-03-15 2017-02-01 Alexion Pharmaceuticals, Inc. Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement
KR102269708B1 (ko) 2008-04-11 2021-06-25 추가이 세이야쿠 가부시키가이샤 복수 분자의 항원에 반복 결합하는 항원 결합 분자
HUE026179T2 (en) 2008-08-05 2016-05-30 Novartis Ag Preparations and methods for antibodies against complement C5 protein
BRPI0921237A2 (pt) 2008-11-10 2015-09-22 Alexion Pharma Inc métodos e composições para o tratamento de distúrbios associados ao complemento
AU2011225716A1 (en) 2010-03-11 2012-09-27 Pfizer Inc. Antibodies with pH dependent antigen binding
TWI667346B (zh) 2010-03-30 2019-08-01 中外製藥股份有限公司 促進抗原消失之具有經修飾的FcRn親和力之抗體
BR112015018438A2 (pt) * 2013-01-31 2017-07-18 Seoul Nat Univ R&Db Foundation anticorpo contra c5 e método para prevenir e tratar doenças relacionadas a complemento
JP6174782B2 (ja) * 2014-12-19 2017-08-02 中外製薬株式会社 抗ｃ５抗体および使用方法
KR101892883B1 (ko) * 2015-02-27 2018-10-05 추가이 세이야쿠 가부시키가이샤 Il-6 관련 질환 치료용 조성물
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Also Published As

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

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