CA3030530C - Regimens and methods of treating multiple sclerosis using ofatumumab - Google Patents

Regimens and methods of treating multiple sclerosis using ofatumumab Download PDF

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Publication number
CA3030530C
CA3030530C CA3030530A CA3030530A CA3030530C CA 3030530 C CA3030530 C CA 3030530C CA 3030530 A CA3030530 A CA 3030530A CA 3030530 A CA3030530 A CA 3030530A CA 3030530 C CA3030530 C CA 3030530C
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Prior art keywords
ofatumumab
regimen
multiple sclerosis
antibody
weeks
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CA3030530A
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English (en)
French (fr)
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CA3030530A1 (en
Inventor
Erik Wallstrom
Marina SAVELIEVA PRAZ
Algirdas Jonas KAKARIEKA WEISSKOPF
Joseph Michael KAHN
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Novartis AG
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Novartis AG
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Priority to CA3101514A priority Critical patent/CA3101514A1/en
Publication of CA3030530A1 publication Critical patent/CA3030530A1/en
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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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • 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 Containing Material From Animals Or Micro-Organisms (AREA)
  • Pressure Welding/Diffusion-Bonding (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
CA3030530A 2016-08-15 2017-08-11 Regimens and methods of treating multiple sclerosis using ofatumumab Active CA3030530C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3101514A CA3101514A1 (en) 2016-08-15 2017-08-11 Regimens and methods of treating multiple sclerosis using ofatumumab

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3101514A Division CA3101514A1 (en) 2016-08-15 2017-08-11 Regimens and methods of treating multiple sclerosis using ofatumumab

Publications (2)

Publication Number Publication Date
CA3030530A1 CA3030530A1 (en) 2018-02-22
CA3030530C true CA3030530C (en) 2021-02-23

Family

ID=59901554

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3030530A Active CA3030530C (en) 2016-08-15 2017-08-11 Regimens and methods of treating multiple sclerosis using ofatumumab
CA3101514A Pending CA3101514A1 (en) 2016-08-15 2017-08-11 Regimens and methods of treating multiple sclerosis using ofatumumab

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3101514A Pending CA3101514A1 (en) 2016-08-15 2017-08-11 Regimens and methods of treating multiple sclerosis using ofatumumab

Country Status (24)

Country Link
US (5) US11161909B2 (https=)
EP (5) EP3497132B1 (https=)
JP (2) JP6851391B2 (https=)
KR (2) KR20200136503A (https=)
CN (5) CN120000782A (https=)
AU (2) AU2017311664C1 (https=)
CA (2) CA3030530C (https=)
CY (1) CY1123350T1 (https=)
DE (1) DE202017007542U1 (https=)
DK (2) DK3733712T3 (https=)
ES (2) ES2954259T3 (https=)
FI (1) FI3733712T3 (https=)
HR (2) HRP20230894T1 (https=)
HU (2) HUE063625T2 (https=)
IL (4) IL302488B2 (https=)
LT (2) LT3733712T (https=)
MX (1) MX388593B (https=)
PL (2) PL3497132T3 (https=)
PT (2) PT3733712T (https=)
RS (2) RS60807B1 (https=)
RU (1) RU2749951C2 (https=)
SI (2) SI3497132T1 (https=)
TW (1) TWI752995B (https=)
WO (1) WO2018033841A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT3733712T (lt) 2016-08-15 2023-09-11 Novartis Ag Išsėtinės sklerozės gydymo schemos ir būdai, panaudojant ofatumumabą
MX2022003010A (es) * 2019-09-11 2022-06-02 Novartis Ag Tratamiento de la emr mediante cambio de terapia.
US20220389109A1 (en) * 2019-09-11 2022-12-08 Novartis Ag Management of conditions other than multiple sclerosis in ofatumumab-treated patients
EP4707302A2 (en) * 2020-04-09 2026-03-11 Novartis AG Ofatumumab for treating ms while maintaining serum igg
WO2022219057A1 (en) * 2021-04-14 2022-10-20 Novartis Ag Ofatumumab for treating multiple sclerosis in asian patients

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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
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DE3689123T2 (de) 1985-11-01 1994-03-03 Xoma Corp Modulare einheit von antikörpergenen, daraus hergestellte antikörper und verwendung.
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
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BRPI0315295C1 (pt) 2002-10-17 2021-05-25 Genmab As anticorpo monoclonal humano isolado, célula hospedeira procariótica, composição farmacêutica, molécula biespecífica, usos de um anticorpo, métodos in vitro de detectar a presença de antígeno de cd20 ou uma célula que expressa cd20 em uma amostra, kit, e, vetor de expressão
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DOP2006000029A (es) 2005-02-07 2006-08-15 Genentech Inc Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas)
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UA107557C2 (xx) 2007-07-06 2015-01-26 Композиція антитіла офатумумабу
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EP2663331A4 (en) * 2011-01-10 2015-07-15 Glaxosmithkline Intellectual Property Man Ltd NEW USES
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WO2015162504A1 (en) 2014-04-23 2015-10-29 Novartis Ag Novel dosing and uses of ofatumumab
WO2015168103A1 (en) 2014-04-29 2015-11-05 Teva Pharmaceutical Industries Ltd. Laquinimod for the treatment of relapsing-remitting multiple sclerosis (rrms) patients with a high disability status
JP2018506275A (ja) * 2015-01-28 2018-03-08 ジェネンテック, インコーポレイテッド 多発性硬化症の遺伝子発現マーカー及び治療
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
LT3733712T (lt) 2016-08-15 2023-09-11 Novartis Ag Išsėtinės sklerozės gydymo schemos ir būdai, panaudojant ofatumumabą
US20220389109A1 (en) 2019-09-11 2022-12-08 Novartis Ag Management of conditions other than multiple sclerosis in ofatumumab-treated patients
MX2022003010A (es) 2019-09-11 2022-06-02 Novartis Ag Tratamiento de la emr mediante cambio de terapia.
EP4707302A2 (en) 2020-04-09 2026-03-11 Novartis AG Ofatumumab for treating ms while maintaining serum igg
WO2022219057A1 (en) 2021-04-14 2022-10-20 Novartis Ag Ofatumumab for treating multiple sclerosis in asian patients
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Publication number Publication date
JP6851391B2 (ja) 2021-03-31
IL302488B1 (en) 2024-08-01
KR20200136503A (ko) 2020-12-07
PT3497132T (pt) 2020-09-25
US12570754B2 (en) 2026-03-10
US20220081488A1 (en) 2022-03-17
RS60807B1 (sr) 2020-10-30
CN120053639A (zh) 2025-05-30
US20240150485A1 (en) 2024-05-09
MX388593B (es) 2025-03-20
US20240317878A1 (en) 2024-09-26
JP2020100630A (ja) 2020-07-02
IL264804B (en) 2020-09-30
CN120037367A (zh) 2025-05-27
MX2019001860A (es) 2019-07-08
AU2017311664A1 (en) 2019-01-31
IL276890A (en) 2020-10-29
PT3733712T (pt) 2023-08-31
AU2020201112B2 (en) 2021-07-22
EP4252847A3 (en) 2023-11-15
DK3733712T3 (da) 2023-08-21
DK3497132T3 (da) 2020-09-07
AU2017311664B2 (en) 2020-01-02
HUE051948T2 (hu) 2021-03-29
EP4711008A2 (en) 2026-03-18
AU2020201112C1 (en) 2025-05-22
HRP20201388T1 (hr) 2020-11-27
ES2954259T3 (es) 2023-11-21
EP3733712A1 (en) 2020-11-04
PL3497132T3 (pl) 2020-11-30
CN109641965A (zh) 2019-04-16
AU2020201112A1 (en) 2020-03-05
JP2019511506A (ja) 2019-04-25
HRP20230894T1 (hr) 2023-11-24
SI3497132T1 (sl) 2020-10-30
WO2018033841A1 (en) 2018-02-22
AU2017311664C1 (en) 2025-05-22
TWI752995B (zh) 2022-01-21
CA3101514A1 (en) 2018-02-22
IL276890B2 (en) 2023-10-01
IL302488A (en) 2023-06-01
EP4371611A2 (en) 2024-05-22
EP3733712B1 (en) 2023-05-24
IL302488B2 (en) 2024-12-01
CN120000782A (zh) 2025-05-16
ES2821924T3 (es) 2021-04-28
HUE063625T2 (hu) 2024-01-28
IL276890B1 (en) 2023-06-01
RS64541B1 (sr) 2023-09-29
CY1123350T1 (el) 2021-12-31
FI3733712T3 (fi) 2023-08-22
CN120053638A (zh) 2025-05-30
TW201808333A (zh) 2018-03-16
RU2019107146A (ru) 2020-09-15
LT3497132T (lt) 2020-10-12
US20190177424A1 (en) 2019-06-13
PL3733712T3 (pl) 2023-10-16
RU2019107146A3 (https=) 2020-09-15
LT3733712T (lt) 2023-09-11
RU2021105514A (ru) 2021-04-19
DE202017007542U1 (de) 2022-07-19
US12338290B2 (en) 2025-06-24
SI3733712T1 (sl) 2023-12-29
EP4252847A2 (en) 2023-10-04
EP4371611A3 (en) 2024-07-24
IL313932A (en) 2024-08-01
US11161909B2 (en) 2021-11-02
JP7198786B2 (ja) 2023-01-04
EP3497132A1 (en) 2019-06-19
CA3030530A1 (en) 2018-02-22
EP3497132B1 (en) 2020-06-24
RU2749951C2 (ru) 2021-06-21
US20250289902A1 (en) 2025-09-18
RU2021105514A3 (https=) 2022-02-08
KR20190038914A (ko) 2019-04-09

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