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

Regimens and methods of treating multiple sclerosis using ofatumumab Download PDF

Info

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
Authority
CA
Canada
Prior art keywords
ofatumumab
regimen
multiple sclerosis
antibody
weeks
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
CA3030530A
Other languages
English (en)
French (fr)
Other versions
CA3030530A1 (en
Inventor
Erik Wallstrom
Marina SAVELIEVA PRAZ
Algirdas Jonas KAKARIEKA WEISSKOPF
Joseph Michael KAHN
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.)
Novartis AG
Original Assignee
Novartis AG
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 Novartis AG filed Critical Novartis AG
Priority to CA3101514A priority Critical patent/CA3101514A1/en
Publication of CA3030530A1 publication Critical patent/CA3030530A1/en
Application granted granted Critical
Publication of CA3030530C publication Critical patent/CA3030530C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Meat, Egg Or Seafood Products (AREA)
  • Pressure Welding/Diffusion-Bonding (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (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) KR20190038914A (https=)
CN (5) CN120053638A (https=)
AU (2) AU2017311664C1 (https=)
CA (2) CA3030530C (https=)
CY (1) CY1123350T1 (https=)
DE (1) DE202017007542U1 (https=)
DK (2) DK3497132T3 (https=)
ES (2) ES2954259T3 (https=)
FI (1) FI3733712T3 (https=)
HR (2) HRP20230894T1 (https=)
HU (2) HUE051948T2 (https=)
IL (4) IL302488B2 (https=)
LT (2) LT3497132T (https=)
MX (1) MX388593B (https=)
PL (2) PL3497132T3 (https=)
PT (2) PT3497132T (https=)
RS (2) RS64541B1 (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
CN120053638A (zh) * 2016-08-15 2025-05-30 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
ES2957112T3 (es) 2019-09-11 2024-01-11 Novartis Ag Tratamiento del RMS mediante cambio de terapia
MX2022003030A (es) 2019-09-11 2022-04-07 Novartis Ag Tratamiento de afecciones distintas de la esclerosis multiple en pacientes tratados con ofatumumab.
US20230151106A1 (en) * 2020-04-09 2023-05-18 Novartis Ag OFATUMUMAB FOR TREATING MS WHILE MAINTAINING SERUM IgG
US20240228647A1 (en) * 2021-04-14 2024-07-11 Novartis Ag Ofatumumab for treating multiple sclerosis in asian patients

Family Cites Families (32)

* 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
JPS63501765A (ja) 1985-11-01 1988-07-21 インタ−ナショナル、ジェネティック、エンジニアリング インコ−ポレ−テッド 抗体遺伝子のモジュ−ル組立体、それにより産生された抗体及び用途
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
DE69232137T2 (de) 1991-11-25 2002-05-29 Enzon Inc Multivalente antigen-bindende proteine
JP2003529361A (ja) 2000-03-30 2003-10-07 アムジェン インコーポレイテッド CD20/IgEレセプター様分子およびその使用
EA013564B1 (ru) 2000-08-03 2010-06-30 Терапеутик Хьюман Поликлоналз Инк. Гуманизированный иммуноглобулин и содержащая его фармацевтическая композиция
CN101928344B (zh) 2002-10-17 2014-08-13 根马布股份公司 抗cd20的人单克隆抗体
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
TW201014605A (en) 2008-09-16 2010-04-16 Genentech Inc Methods for treating progressive multiple sclerosis
WO2012018704A1 (en) 2010-08-02 2012-02-09 Sanofi-Aventis U.S. Llc Use of teriflunomide for treating multiple sclerosis
EP2663331A4 (en) 2011-01-10 2015-07-15 Glaxosmithkline Intellectual Property Man Ltd NEW USES
TWI606064B (zh) * 2012-02-08 2017-11-21 Igm生物科技公司 細胞死亡誘導分子(cdim)結合蛋白類及彼等之用途
EP2692343A1 (en) 2012-08-03 2014-02-05 Forward Pharma A/S Combination therapy for treatment of multiple sclerosis
SG11201500499TA (en) 2012-08-10 2015-03-30 Boehringer Ingelheim Int 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
EA201692180A1 (ru) 2014-04-29 2017-08-31 Тева Фармасьютикал Индастриз Лтд. Лахинимод для лечения пациентов с рецидивирующе-ремиттирующим рассеянным склерозом (рррс) с высоким статусом инвалидизации
WO2016123329A2 (en) * 2015-01-28 2016-08-04 Genentech, Inc. 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
CN120053638A (zh) 2016-08-15 2025-05-30 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
ES2957112T3 (es) 2019-09-11 2024-01-11 Novartis Ag Tratamiento del RMS mediante cambio de terapia
MX2022003030A (es) 2019-09-11 2022-04-07 Novartis Ag Tratamiento de afecciones distintas de la esclerosis multiple en pacientes tratados con ofatumumab.
US20230151106A1 (en) 2020-04-09 2023-05-18 Novartis Ag OFATUMUMAB FOR TREATING MS WHILE MAINTAINING SERUM IgG
US20240228647A1 (en) 2021-04-14 2024-07-11 Novartis Ag Ofatumumab for treating multiple sclerosis in asian patients
IL310813A (en) 2021-08-16 2024-04-01 Novartis Ag OFATUMUMAB for the treatment of multiple sclerosis in children

Also Published As

Publication number Publication date
PL3497132T3 (pl) 2020-11-30
SI3733712T1 (sl) 2023-12-29
US20240150485A1 (en) 2024-05-09
IL313932A (en) 2024-08-01
US11161909B2 (en) 2021-11-02
EP3497132B1 (en) 2020-06-24
IL264804B (en) 2020-09-30
RU2021105514A (ru) 2021-04-19
JP6851391B2 (ja) 2021-03-31
WO2018033841A1 (en) 2018-02-22
US12338290B2 (en) 2025-06-24
JP2020100630A (ja) 2020-07-02
CN120037367A (zh) 2025-05-27
JP2019511506A (ja) 2019-04-25
HUE051948T2 (hu) 2021-03-29
SI3497132T1 (sl) 2020-10-30
MX388593B (es) 2025-03-20
EP3497132A1 (en) 2019-06-19
CA3030530A1 (en) 2018-02-22
EP4252847A2 (en) 2023-10-04
AU2020201112C1 (en) 2025-05-22
RS60807B1 (sr) 2020-10-30
EP4371611A3 (en) 2024-07-24
US20240317878A1 (en) 2024-09-26
JP7198786B2 (ja) 2023-01-04
AU2017311664B2 (en) 2020-01-02
HUE063625T2 (hu) 2024-01-28
EP4371611A2 (en) 2024-05-22
CY1123350T1 (el) 2021-12-31
EP4252847A3 (en) 2023-11-15
TWI752995B (zh) 2022-01-21
US20220081488A1 (en) 2022-03-17
CN120000782A (zh) 2025-05-16
AU2017311664C1 (en) 2025-05-22
IL302488A (en) 2023-06-01
RU2021105514A3 (https=) 2022-02-08
RU2749951C2 (ru) 2021-06-21
IL302488B1 (en) 2024-08-01
PT3497132T (pt) 2020-09-25
HRP20230894T1 (hr) 2023-11-24
IL276890B2 (en) 2023-10-01
US12570754B2 (en) 2026-03-10
EP4711008A2 (en) 2026-03-18
AU2020201112A1 (en) 2020-03-05
CN109641965A (zh) 2019-04-16
EP3733712A1 (en) 2020-11-04
AU2020201112B2 (en) 2021-07-22
MX2019001860A (es) 2019-07-08
LT3497132T (lt) 2020-10-12
US20190177424A1 (en) 2019-06-13
PL3733712T3 (pl) 2023-10-16
IL276890B1 (en) 2023-06-01
IL302488B2 (en) 2024-12-01
KR20200136503A (ko) 2020-12-07
RS64541B1 (sr) 2023-09-29
KR20190038914A (ko) 2019-04-09
AU2017311664A1 (en) 2019-01-31
LT3733712T (lt) 2023-09-11
DE202017007542U1 (de) 2022-07-19
IL276890A (en) 2020-10-29
ES2954259T3 (es) 2023-11-21
EP3733712B1 (en) 2023-05-24
CA3101514A1 (en) 2018-02-22
PT3733712T (pt) 2023-08-31
RU2019107146A (ru) 2020-09-15
ES2821924T3 (es) 2021-04-28
HRP20201388T1 (hr) 2020-11-27
DK3497132T3 (da) 2020-09-07
FI3733712T3 (fi) 2023-08-22
US20250289902A1 (en) 2025-09-18
RU2019107146A3 (https=) 2020-09-15
TW201808333A (zh) 2018-03-16
CN120053639A (zh) 2025-05-30
DK3733712T3 (da) 2023-08-21
CN120053638A (zh) 2025-05-30

Similar Documents

Publication Publication Date Title
US12570754B2 (en) Regimens and methods of treating multiple sclerosis using ofatumumab
HK40101642A (en) Regimens and methods of treating multiple sclerosis using ofatumumab
HK40111448A (en) Regimens and methods of treating multiple sclerosis using ofatumumab
RU2782069C2 (ru) Схемы и способы лечения рассеянного склероза с применением офатумумаба
HK40032047A (en) Regimens and methods of treating multiple sclerosis using ofatumumab
HK40032047B (en) Regimens and methods of treating multiple sclerosis using ofatumumab
HK40005527B (en) Regimens and methods of treating multiple sclerosis using ofatumumab
HK40005527A (en) Regimens and methods of treating multiple sclerosis using ofatumumab

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20200211

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 7TH ANNIV.) - STANDARD

Year of fee payment: 7

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20240726

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20240726

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 8TH ANNIV.) - STANDARD

Year of fee payment: 8

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250722

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250722

R00 Party data change recorded

Free format text: ST27 STATUS EVENT CODE: A-4-4-R10-R00-R119 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REVOCATION OF AGENT REQUEST

Effective date: 20250829

Free format text: ST27 STATUS EVENT CODE: A-4-4-R10-R00-R116 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPOINTMENT OF AGENT REQUEST

Effective date: 20250829

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-4-4-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250829

R17 Change to representative recorded

Free format text: ST27 STATUS EVENT CODE: A-4-4-R10-R17-R117 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPOINTMENT OF AGENT REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20250909

Free format text: ST27 STATUS EVENT CODE: A-4-4-R10-R17-R121 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REVOCATION OF AGENT REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20250909

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-4-4-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20250909