RU2749951C2 - Схемы и способы лечения рассеянного склероза с применением офатумумаба - Google Patents

Схемы и способы лечения рассеянного склероза с применением офатумумаба Download PDF

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RU2749951C2
RU2749951C2 RU2019107146A RU2019107146A RU2749951C2 RU 2749951 C2 RU2749951 C2 RU 2749951C2 RU 2019107146 A RU2019107146 A RU 2019107146A RU 2019107146 A RU2019107146 A RU 2019107146A RU 2749951 C2 RU2749951 C2 RU 2749951C2
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ofatumumab
day
multiple sclerosis
regimen
dose
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RU2019107146A
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RU2019107146A (ru
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Эрик Валлстрём
Марина САВЕЛЬЕВА ПРАС
Алгирдас Йонас КАКАРИКА ВАЙССКОПФ
Джозеф Майкл КАН
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Новартис Аг
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • 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
    • 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
    • A61K2039/54Medicinal 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
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
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  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Meat, Egg Or Seafood Products (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pressure Welding/Diffusion-Bonding (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
RU2019107146A 2016-08-15 2017-08-11 Схемы и способы лечения рассеянного склероза с применением офатумумаба RU2749951C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662374986P 2016-08-15 2016-08-15
US62/374,986 2016-08-15
PCT/IB2017/054909 WO2018033841A1 (en) 2016-08-15 2017-08-11 Regimens and methods of treating multiple sclerosis using ofatumumab

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Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109641965A (zh) * 2016-08-15 2019-04-16 诺华股份有限公司 使用奥法木单抗治疗多发性硬化的方案和方法
CN118403156A (zh) 2019-09-11 2024-07-30 诺华股份有限公司 通过转换疗法治疗rms
US20220389109A1 (en) * 2019-09-11 2022-12-08 Novartis Ag Management of conditions other than multiple sclerosis in ofatumumab-treated patients
IL296701A (en) * 2020-04-09 2022-11-01 Novartis Ag Ofatumumab for the treatment of multiple sclerosis while maintaining IgG in the serum
WO2022219057A1 (en) * 2021-04-14 2022-10-20 Novartis Ag Ofatumumab for treating multiple sclerosis in asian patients

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012096924A1 (en) * 2011-01-10 2012-07-19 Glaxo Group Limited Novel uses

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
JPS6147500A (ja) 1984-08-15 1986-03-07 Res Dev Corp Of Japan キメラモノクロ−ナル抗体及びその製造法
EP0173494A3 (en) 1984-08-27 1987-11-25 The Board Of Trustees Of The Leland Stanford Junior University Chimeric receptors by dna splicing and expression
GB8422238D0 (en) 1984-09-03 1984-10-10 Neuberger M S Chimeric proteins
JPS61134325A (ja) 1984-12-04 1986-06-21 Teijin Ltd ハイブリツド抗体遺伝子の発現方法
US4816401A (en) 1985-09-09 1989-03-28 University Of Rochester Serum free cell culture medium
WO1987002671A1 (en) 1985-11-01 1987-05-07 International Genetic Engineering, Inc. Modular assembly of antibody genes, antibodies prepared thereby and use
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
AU3178993A (en) 1991-11-25 1993-06-28 Enzon, Inc. Multivalent antigen-binding proteins
AU5108201A (en) 2000-03-30 2001-10-15 Amgen Inc Cd20/ige-receptor like molecules and uses thereof
CA2634294A1 (en) 2000-08-03 2002-02-14 Therapeutic Human Polyclonals, Inc. Production of humanized antibodies in transgenic animals
WO2004035607A2 (en) 2002-10-17 2004-04-29 Genmab A/S Human monoclonal antibodies against cd20
US8084582B2 (en) 2003-03-03 2011-12-27 Xencor, Inc. Optimized anti-CD20 monoclonal antibodies having Fc variants
DOP2006000029A (es) 2005-02-07 2006-08-15 Genentech Inc Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas)
US10155816B2 (en) 2005-11-28 2018-12-18 Genmab A/S Recombinant monovalent antibodies and methods for production thereof
UA107557C2 (xx) * 2007-07-06 2015-01-26 Композиція антитіла офатумумабу
TW201438738A (zh) 2008-09-16 2014-10-16 Genentech Inc 治療進展型多發性硬化症之方法
EP2600861A1 (en) 2010-08-02 2013-06-12 Sanofi-Aventis U.S. LLC Use of teriflunomide for treating multiple sclerosis
MX363819B (es) * 2012-02-08 2019-04-03 Igm Biosciences Inc Uniones a cdim y sus usos.
EP2692343A1 (en) 2012-08-03 2014-02-05 Forward Pharma A/S Combination therapy for treatment of multiple sclerosis
EP2882741B1 (en) * 2012-08-10 2018-10-24 Boehringer Ingelheim International GmbH Heteroaromatic compounds as bruton's tyrosine kinase (btk) inhibitors
WO2015162504A1 (en) 2014-04-23 2015-10-29 Novartis Ag Novel dosing and uses of ofatumumab
UY36099A (es) 2014-04-29 2016-02-29 Teva Pharma Laquinimod para el tratamiento de pacientes con esclerosis múltiple remitente recurrente (rrms) con un alto grado de discapacidad
EP3250927B1 (en) 2015-01-28 2020-02-19 H. Hoffnabb-La Roche Ag Gene expression markers and treatment of multiple sclerosis
CN106699886A (zh) 2015-07-13 2017-05-24 西藏海思科药业集团股份有限公司 抗体依赖性细胞介导的细胞毒性(adcc)增强的奥法木抗体
CN109641965A (zh) 2016-08-15 2019-04-16 诺华股份有限公司 使用奥法木单抗治疗多发性硬化的方案和方法
CN118403156A (zh) 2019-09-11 2024-07-30 诺华股份有限公司 通过转换疗法治疗rms
US20220389109A1 (en) 2019-09-11 2022-12-08 Novartis Ag Management of conditions other than multiple sclerosis in ofatumumab-treated patients
IL296701A (en) 2020-04-09 2022-11-01 Novartis Ag Ofatumumab for the treatment of multiple sclerosis while maintaining IgG in the serum
WO2022219057A1 (en) 2021-04-14 2022-10-20 Novartis Ag Ofatumumab for treating multiple sclerosis in asian patients
US20240343821A1 (en) 2021-08-16 2024-10-17 Novartis Ag Ofatumumab for treating pediatric ms

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012096924A1 (en) * 2011-01-10 2012-07-19 Glaxo Group Limited Novel uses

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
BAR-OR A. et al. The MIRROR study: A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the safety and MRI efficacy of subcutaneous ofatumumab in subjects with relapsing-remitting multiple sclerosis (RRMS)(S23. 006). - 2014. *
Genmab Announces Phase III Studies of Ofatumumab in Relapsing Multiple Sclerosis, 02.06.2016, [электронный ресурс] - URL: https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-iii-studies-ofatumumab-relapsing-multiple/. *
Genmab Announces Phase III Studies of Ofatumumab in Relapsing Multiple Sclerosis, 02.06.2016, [электронный ресурс] - URL: https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-iii-studies-ofatumumab-relapsing-multiple/. BAR-OR A. et al. The MIRROR study: A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the safety and MRI efficacy of subcutaneous ofatumumab in subjects with relapsing-remitting multiple sclerosis (RRMS)(S23. 006). - 2014. SORENSENPS et al. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. Neurology, 2014, 82(7):573-81. *
SORENSEN PS et al. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. Neurology, 2014, 82(7):573-81. *

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CA3101514A1 (en) 2018-02-22
JP7198786B2 (ja) 2023-01-04
AU2020201112C1 (en) 2025-05-22
IL302488B2 (en) 2024-12-01
CN120053638A (zh) 2025-05-30
SI3733712T1 (sl) 2023-12-29
CA3030530A1 (en) 2018-02-22
IL313932A (en) 2024-08-01
IL276890B1 (en) 2023-06-01
PT3497132T (pt) 2020-09-25
IL276890A (en) 2020-10-29
EP3497132B1 (en) 2020-06-24
AU2017311664C1 (en) 2025-05-22
EP4371611A2 (en) 2024-05-22
SI3497132T1 (sl) 2020-10-30
RU2019107146A3 (enExample) 2020-09-15
HUE051948T2 (hu) 2021-03-29
RU2021105514A3 (enExample) 2022-02-08
EP4252847A2 (en) 2023-10-04
US20220081488A1 (en) 2022-03-17
WO2018033841A1 (en) 2018-02-22
KR20190038914A (ko) 2019-04-09
DK3497132T3 (da) 2020-09-07
US20250289902A1 (en) 2025-09-18
HUE063625T2 (hu) 2024-01-28
AU2017311664B2 (en) 2020-01-02
PL3497132T3 (pl) 2020-11-30
CN120053639A (zh) 2025-05-30
US12338290B2 (en) 2025-06-24
RU2019107146A (ru) 2020-09-15
RS64541B1 (sr) 2023-09-29
DE202017007542U1 (de) 2022-07-19
LT3497132T (lt) 2020-10-12
US20190177424A1 (en) 2019-06-13
TWI752995B (zh) 2022-01-21
MX2019001860A (es) 2019-07-08
EP3497132A1 (en) 2019-06-19
TW201808333A (zh) 2018-03-16
EP4252847A3 (en) 2023-11-15
IL264804B (en) 2020-09-30
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US20240150485A1 (en) 2024-05-09
JP2020100630A (ja) 2020-07-02
FI3733712T3 (fi) 2023-08-22
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CN120037367A (zh) 2025-05-27
IL302488B1 (en) 2024-08-01
ES2954259T3 (es) 2023-11-21
DK3733712T3 (da) 2023-08-21
CY1123350T1 (el) 2021-12-31
AU2020201112A1 (en) 2020-03-05
KR20200136503A (ko) 2020-12-07
CN120000782A (zh) 2025-05-16
RS60807B1 (sr) 2020-10-30
LT3733712T (lt) 2023-09-11
US11161909B2 (en) 2021-11-02
RU2021105514A (ru) 2021-04-19
US20240317878A1 (en) 2024-09-26
CN109641965A (zh) 2019-04-16
CA3030530C (en) 2021-02-23
HRP20230894T1 (hr) 2023-11-24
EP4371611A3 (en) 2024-07-24
PT3733712T (pt) 2023-08-31
MX388593B (es) 2025-03-20
JP6851391B2 (ja) 2021-03-31
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AU2020201112B2 (en) 2021-07-22
EP3733712A1 (en) 2020-11-04
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AU2017311664A1 (en) 2019-01-31
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