AU2020322165A1 - Dosage and administration regimen for the treatment or prevention of C5-related diseases by the use of the anti-C5 antibody Crovalimab - Google Patents

Dosage and administration regimen for the treatment or prevention of C5-related diseases by the use of the anti-C5 antibody Crovalimab Download PDF

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Publication number
AU2020322165A1
AU2020322165A1 AU2020322165A AU2020322165A AU2020322165A1 AU 2020322165 A1 AU2020322165 A1 AU 2020322165A1 AU 2020322165 A AU2020322165 A AU 2020322165A AU 2020322165 A AU2020322165 A AU 2020322165A AU 2020322165 A1 AU2020322165 A1 AU 2020322165A1
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Australia
Prior art keywords
antibody
subject
crovalimab
dose
patients
Prior art date
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Pending
Application number
AU2020322165A
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English (en)
Inventor
Simon Bertrand Marie BUATOIS
Christoph Bucher
Jean-Eric Charoin
Félix Grégoire Jason JAMINION
Gregor JORDAN
Alexandre Antoine Bernard SOSTELLY
Antoine SOUBRET
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Publication of AU2020322165A1 publication Critical patent/AU2020322165A1/en
Pending legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Pain & Pain Management (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
AU2020322165A 2019-07-31 2020-07-30 Dosage and administration regimen for the treatment or prevention of C5-related diseases by the use of the anti-C5 antibody Crovalimab Pending AU2020322165A1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
EP19189442 2019-07-31
EP19189442.7 2019-07-31
EP20174790 2020-05-14
EP20174790.4 2020-05-14
EP20179591.1 2020-06-11
EP20179591 2020-06-11
PCT/EP2020/071555 WO2021019036A1 (en) 2019-07-31 2020-07-30 Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab

Publications (1)

Publication Number Publication Date
AU2020322165A1 true AU2020322165A1 (en) 2022-01-06

Family

ID=71846415

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020322165A Pending AU2020322165A1 (en) 2019-07-31 2020-07-30 Dosage and administration regimen for the treatment or prevention of C5-related diseases by the use of the anti-C5 antibody Crovalimab

Country Status (12)

Country Link
US (1) US20220275070A1 (enExample)
EP (1) EP4003409A1 (enExample)
JP (2) JP7437261B2 (enExample)
KR (2) KR20240033090A (enExample)
CN (2) CN115068604A (enExample)
AU (1) AU2020322165A1 (enExample)
CA (1) CA3144923A1 (enExample)
CR (1) CR20220041A (enExample)
IL (1) IL288600A (enExample)
MX (1) MX2022001154A (enExample)
TW (1) TWI886140B (enExample)
WO (1) WO2021019036A1 (enExample)

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
EP0307434B2 (en) 1987-03-18 1998-07-29 Scotgen Biopharmaceuticals, Inc. Altered antibodies
CA2103059C (en) 1991-06-14 2005-03-22 Paul J. Carter Method for making humanized antibodies
WO1994029351A2 (en) 1993-06-16 1994-12-22 Celltech 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
DK1068241T3 (da) 1998-04-02 2008-02-04 Genentech Inc Antistofvarianter og fragmenter deraf
US6194551B1 (en) 1998-04-02 2001-02-27 Genentech, Inc. Polypeptide variants
US6737056B1 (en) 1999-01-15 2004-05-18 Genentech, Inc. Polypeptide variants with altered effector function
ES2694002T3 (es) 1999-01-15 2018-12-17 Genentech, Inc. Polipéptido que comprende una región Fc de IgG1 humana variante
WO2002030985A2 (en) 2000-10-10 2002-04-18 Tanox, Inc. Inhibition of complement c5 activation for the treatment and prevention of delayed xenograft or acute vascular rejection
AU2002331601B2 (en) 2001-08-17 2006-04-13 Tanox, Inc. Complement pathway inhibitors binding to C5 and C5a without preventing the formation of C5b
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
AR042485A1 (es) 2002-12-16 2005-06-22 Genentech Inc Anticuerpo humanizado que se une al cd20 humano
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
CA2885854C (en) 2004-04-13 2017-02-21 F. Hoffmann-La Roche Ag Anti-p-selectin antibodies
TWI309240B (en) 2004-09-17 2009-05-01 Hoffmann La Roche Anti-ox40l antibodies
WO2007106585A1 (en) 2006-03-15 2007-09-20 Alexion Pharmaceuticals, Inc. Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement
BRPI0916668B1 (pt) 2008-08-05 2021-12-28 Novartis Ag Anticorpo monoclonal isolado, composição farmacêutica, ácido nucleico isolado e vetor
CN109045296A (zh) 2008-11-10 2018-12-21 阿雷克森制药公司 用于治疗补体相关障碍的方法和组合物
AR103162A1 (es) * 2014-12-19 2017-04-19 Chugai Pharmaceutical Co Ltd Anticuerpos anti-c5 y métodos para su uso
IL259256B2 (en) 2015-12-18 2023-02-01 Chugai Pharmaceutical Co Ltd Anti-c5 antibodies and methods of use
EP3402816A1 (en) 2016-01-11 2018-11-21 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
MA53248A (fr) 2016-01-25 2022-02-16 Takeda Pharmaceuticals Co Anticorps anti-c5 à commutation ph améliorée
CN110087683A (zh) * 2016-12-16 2019-08-02 三星Bioepis股份有限公司 稳定水性抗c5抗体组合物
WO2018143266A1 (en) * 2017-01-31 2018-08-09 Chugai Seiyaku Kabushiki Kaisha 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
BR112020008182A2 (pt) * 2017-10-26 2020-10-27 Alexion Pharmaceuticals, Inc. dosagem e administração de anticorpos anti-c5 para tratamento de hemoglobinúria paroxística noturna (hpn) e síndrome hemolítica urêmica atípica (shua)

Also Published As

Publication number Publication date
JP2022101535A (ja) 2022-07-06
KR20240033090A (ko) 2024-03-12
JP2021038198A (ja) 2021-03-11
US20220275070A1 (en) 2022-09-01
IL288600A (en) 2022-02-01
TWI886140B (zh) 2025-06-11
KR20210016333A (ko) 2021-02-15
EP4003409A1 (en) 2022-06-01
TW202120125A (zh) 2021-06-01
CA3144923A1 (en) 2021-02-04
CN114929273A (zh) 2022-08-19
CN115068604A (zh) 2022-09-20
CR20220041A (es) 2022-03-02
JP7748311B2 (ja) 2025-10-02
JP7437261B2 (ja) 2024-02-22
MX2022001154A (es) 2022-02-22
WO2021019036A1 (en) 2021-02-04

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