AR068531A1 - Dosis fija por inyeccion unica para ocrelizumab (2h7). uso de rituximab. formulacion farmaceutica. kit. - Google Patents

Dosis fija por inyeccion unica para ocrelizumab (2h7). uso de rituximab. formulacion farmaceutica. kit.

Info

Publication number
AR068531A1
AR068531A1 ARP080104116A ARP080104116A AR068531A1 AR 068531 A1 AR068531 A1 AR 068531A1 AR P080104116 A ARP080104116 A AR P080104116A AR P080104116 A ARP080104116 A AR P080104116A AR 068531 A1 AR068531 A1 AR 068531A1
Authority
AR
Argentina
Prior art keywords
antagonist
antibody
use according
pharmaceutical formulation
administration
Prior art date
Application number
ARP080104116A
Other languages
English (en)
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of AR068531A1 publication Critical patent/AR068531A1/es

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Classifications

    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • 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
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • 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
    • A61K2039/545Medicinal 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
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (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)
  • Medicinal Preparation (AREA)

Abstract

Uso de un antagonista de CD20 en la fabricacion de un medicamento para el tratamiento de una enfermedad autoinmune, en donde el medicamento es para la administracion a un paciente humano en una infusion intravenosa (i.v.) unica, terapéuticamente eficaz, de dicho antagonista. El antagonista de CD20 preferentemente es un anticuerpo de CD20, y la enfermedad autoinmune preferentemente es artritis reumatoidea. Reivindicacion 4: El uso segun una cualquiera de las reivindicaciones de 1 a 3, en el que el antagonista del CD20 es un anticuerpo monoclonal del CD20. Reivindicacion 6: El uso segun una cualquiera de las reivindicaciones 4 o 5, en el que el anticuerpo monoclonal de CD20 es quimérico, humanizado o humano. Reivindicacion 26: El uso segun una cualquiera de las reivindicaciones de 1 a 25, en el que el anticuerpo de CD20 está destinado a la administracion en combinacion con un fármaco elegido entre el grupo formado por los fármacos antiinflamatorios no esteroideos (NSAID), los analgésicos, los glucocorticosteroides, la ciclofosfamida, el adalimumab, la leflunomida, el infliximab, el etanercept, el ofatumumab, el tocilizumab, el AME-133, el lmmu-106 y los inhibidores de COX-2. Reivindicacion 27: El uso segun una cualquiera de las reivindicaciones de 1 a 26, para administracion que contiene un segundo agente terapéutico. Reivindicacion 29: El uso segun una cualquiera de las reivindicaciones de 1 a 28, en el que el segundo agente terapéutico es el metotrexato. Reivindicacion 50: Un articulo fabricado que contiene (a) un contenedor que contiene un antagonista de CD20; y (b) un prospecto con instrucciones para tratar una enfermedad autoinmune en un sujeto humano, dichas instrucciones indican la cantidad terapéuticamente eficaz completa del antagonista del CD20 que se tiene que administrar al sujeto en forma de infusion intravenosa unica. Reivindicacion 58: Una formulacion farmacéutica que contiene una cantidad eficaz completa de un anticuerpo de CD20 en una forma apropiada para la administracion intravenosa una sola vez. Reivindicacion 59: La formulacion farmacéutica de la reivindicacion 58, en la que el anticuerpo de CD20 es la variante 2H7 A humanizada que contiene una cadena L de longitud completa de SEQ ID N°: 6 y una cadena H de longitud completa de SEQ ID N°: 7, o un fragmento de la misma. Reivindicacion 62: La formulacion farmacéutica segun una cualquiera de las reivindicaciones de 58 a 61, en la que dicha variante 2H7 A humanizada se formula a razon de 20 mg/mI de anticuerpo en histidina sulfato 10 mM, 60 mg/mI de sucrosa, 0,2 mg/mI de polisorbato 20 y agua estéril para inyeccion, de pH = 5,8.
ARP080104116A 2007-09-24 2008-09-22 Dosis fija por inyeccion unica para ocrelizumab (2h7). uso de rituximab. formulacion farmaceutica. kit. AR068531A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US97464107P 2007-09-24 2007-09-24
GBGB0718684.4A GB0718684D0 (en) 2007-09-24 2007-09-24 Treatment method

Publications (1)

Publication Number Publication Date
AR068531A1 true AR068531A1 (es) 2009-11-18

Family

ID=38670460

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP080104116A AR068531A1 (es) 2007-09-24 2008-09-22 Dosis fija por inyeccion unica para ocrelizumab (2h7). uso de rituximab. formulacion farmaceutica. kit.

Country Status (10)

Country Link
EP (1) EP2197916A1 (es)
JP (1) JP2011501734A (es)
CN (1) CN101809036A (es)
AR (1) AR068531A1 (es)
CA (1) CA2700351A1 (es)
CL (1) CL2008002817A1 (es)
GB (1) GB0718684D0 (es)
PE (1) PE20091078A1 (es)
TW (1) TW200918091A (es)
WO (1) WO2009040268A1 (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT2380911T (lt) 2003-11-05 2018-07-10 Roche Glycart Ag Antigeną surišančios molekulės, pasižyminčios padidintu fc receptoriaus surišimo afiniškumu ir efektoriaus funkcija
TW201014605A (en) 2008-09-16 2010-04-16 Genentech Inc Methods for treating progressive multiple sclerosis
CN108431038A (zh) * 2015-10-06 2018-08-21 豪夫迈·罗氏有限公司 治疗多发性硬化的方法
JP7166925B2 (ja) * 2016-03-07 2022-11-08 サノフィ・バイオテクノロジー 関節リウマチを処置するための組成物及び方法
MY202382A (en) * 2017-08-08 2024-04-24 Hoffmann La Roche Obinutuzumab treatment of a dlbcl patient subgroup
AU2019347730A1 (en) * 2018-09-24 2021-03-25 Janssen Biotech, Inc. Method of providing safe administration of an anti-CD154 antibody

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI2289936T1 (sl) * 2002-12-16 2017-10-30 Genentech, Inc. Imunoglobulinske variante in njihove uporabe
JP2008526998A (ja) * 2005-01-13 2008-07-24 ジェネンテック・インコーポレーテッド 治療方法
BRPI0614183A2 (pt) * 2005-07-25 2011-03-15 Trubion Pharmaceuticals Inc uso de dose única de moléculas de ligação especìficas para cd20
MY149159A (en) * 2005-11-15 2013-07-31 Hoffmann La Roche Method for treating joint damage

Also Published As

Publication number Publication date
GB0718684D0 (en) 2007-10-31
TW200918091A (en) 2009-05-01
CA2700351A1 (en) 2009-04-02
PE20091078A1 (es) 2009-07-23
EP2197916A1 (en) 2010-06-23
CL2008002817A1 (es) 2009-10-16
JP2011501734A (ja) 2011-01-13
CN101809036A (zh) 2010-08-18
WO2009040268A1 (en) 2009-04-02

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