TWI752995B - 使用奧法木單抗（ofatumumab）治療多發性硬化症之療程及方法 - Google Patents

使用奧法木單抗（ofatumumab）治療多發性硬化症之療程及方法 Download PDF

Info

Publication number
TWI752995B
TWI752995B TW106127565A TW106127565A TWI752995B TW I752995 B TWI752995 B TW I752995B TW 106127565 A TW106127565 A TW 106127565A TW 106127565 A TW106127565 A TW 106127565A TW I752995 B TWI752995 B TW I752995B
Authority
TW
Taiwan
Prior art keywords
ofatumumab
dose
course
multiple sclerosis
during
Prior art date
Application number
TW106127565A
Other languages
English (en)
Chinese (zh)
Other versions
TW201808333A (zh
Inventor
艾瑞克 渥史東厄
瑪麗娜 莎菲利法 普拉茲
阿爾吉爾達斯 瓊斯 卡卡利卡 維斯可夫
約瑟夫 麥可 卡恩
Original Assignee
瑞士商諾華公司
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 瑞士商諾華公司 filed Critical 瑞士商諾華公司
Publication of TW201808333A publication Critical patent/TW201808333A/zh
Application granted granted Critical
Publication of TWI752995B publication Critical patent/TWI752995B/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins 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)
  • 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)
TW106127565A 2016-08-15 2017-08-15 使用奧法木單抗（ofatumumab）治療多發性硬化症之療程及方法 TWI752995B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662374986P 2016-08-15 2016-08-15
US62/374,986 2016-08-15

Publications (2)

Publication Number Publication Date
TW201808333A TW201808333A (zh) 2018-03-16
TWI752995B true TWI752995B (zh) 2022-01-21

Family

ID=59901554

Family Applications (1)

Application Number Title Priority Date Filing Date
TW106127565A TWI752995B (zh) 2016-08-15 2017-08-15 使用奧法木單抗（ofatumumab）治療多發性硬化症之療程及方法

Country Status (24)

Country Link
US (5) US11161909B2 (cg-RX-API-DMAC7.html)
EP (4) EP3497132B1 (cg-RX-API-DMAC7.html)
JP (2) JP6851391B2 (cg-RX-API-DMAC7.html)
KR (2) KR20190038914A (cg-RX-API-DMAC7.html)
CN (5) CN120053638A (cg-RX-API-DMAC7.html)
AU (2) AU2017311664C1 (cg-RX-API-DMAC7.html)
CA (2) CA3030530C (cg-RX-API-DMAC7.html)
CY (1) CY1123350T1 (cg-RX-API-DMAC7.html)
DE (1) DE202017007542U1 (cg-RX-API-DMAC7.html)
DK (2) DK3733712T3 (cg-RX-API-DMAC7.html)
ES (2) ES2954259T3 (cg-RX-API-DMAC7.html)
FI (1) FI3733712T3 (cg-RX-API-DMAC7.html)
HR (2) HRP20230894T1 (cg-RX-API-DMAC7.html)
HU (2) HUE063625T2 (cg-RX-API-DMAC7.html)
IL (4) IL276890B2 (cg-RX-API-DMAC7.html)
LT (2) LT3497132T (cg-RX-API-DMAC7.html)
MX (1) MX388593B (cg-RX-API-DMAC7.html)
PL (2) PL3497132T3 (cg-RX-API-DMAC7.html)
PT (2) PT3733712T (cg-RX-API-DMAC7.html)
RS (2) RS60807B1 (cg-RX-API-DMAC7.html)
RU (1) RU2749951C2 (cg-RX-API-DMAC7.html)
SI (2) SI3497132T1 (cg-RX-API-DMAC7.html)
TW (1) TWI752995B (cg-RX-API-DMAC7.html)
WO (1) WO2018033841A1 (cg-RX-API-DMAC7.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190038914A (ko) * 2016-08-15 2019-04-09 노파르티스 아게 오파투무맙을 사용한 다발성 경화증의 치료 요법 및 방법
CN118436777A (zh) 2019-09-11 2024-08-06 诺华股份有限公司 通过转换疗法治疗rms
CA3152192A1 (en) * 2019-09-11 2021-03-18 Novartis Ag Management of conditions other than multiple sclerosis in ofatumumab-treated patients
KR20220166827A (ko) * 2020-04-09 2022-12-19 노파르티스 아게 혈청 IgG를 유지하면서 MS를 치료하기 위한 오파투무맙
JP2024514126A (ja) * 2021-04-14 2024-03-28 ノバルティス アーゲー アジア人患者における多発性硬化症を治療するためのオファツムマブ

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
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
AU3178993A (en) 1991-11-25 1993-06-28 Enzon, Inc. Multivalent antigen-binding proteins
EP1272518A2 (en) 2000-03-30 2003-01-08 Amgen, Inc. Cd20/ige-receptor like molecules and uses thereof
EP1311530A4 (en) 2000-08-03 2004-10-06 Wim-Van Schooten PRODUCTION OF HUMANIZED ANTIBODIES IN TRANSGENIC ANIMALS
CN103709250B (zh) 2002-10-17 2016-08-10 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)
EP1973576B1 (en) 2005-11-28 2019-05-15 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
AR082436A1 (es) 2010-08-02 2012-12-05 Sanofi Aventis Us Llc Uso de teriflunomida para tratar la esclerosis multiple
KR102102111B1 (ko) * 2012-02-08 2020-04-20 아이쥐엠 바이오사이언스 인코포레이티드 Ｃｄｉｍ 결합 단백질 및 이의 용도
EP2692343A1 (en) 2012-08-03 2014-02-05 Forward Pharma A/S Combination therapy for treatment of multiple sclerosis
JP6348492B2 (ja) * 2012-08-10 2018-06-27 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング ブルトン型チロシンキナーゼ（ｂｔｋ）阻害剤としてのヘテロ芳香族化合物
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
CN107407677B (zh) 2015-01-28 2020-07-17 豪夫迈·罗氏有限公司 多发性硬化的基因表达标志和治疗
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
KR20190038914A (ko) 2016-08-15 2019-04-09 노파르티스 아게 오파투무맙을 사용한 다발성 경화증의 치료 요법 및 방법
CA3152192A1 (en) 2019-09-11 2021-03-18 Novartis Ag Management of conditions other than multiple sclerosis in ofatumumab-treated patients
CN118436777A (zh) 2019-09-11 2024-08-06 诺华股份有限公司 通过转换疗法治疗rms
KR20220166827A (ko) 2020-04-09 2022-12-19 노파르티스 아게 혈청 IgG를 유지하면서 MS를 치료하기 위한 오파투무맙
JP2024514126A (ja) 2021-04-14 2024-03-28 ノバルティス アーゲー アジア人患者における多発性硬化症を治療するためのオファツムマブ
KR20240046200A (ko) 2021-08-16 2024-04-08 노파르티스 아게 소아 ms 치료를 위한 오파투무맙

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 (3)

* Cited by examiner, † Cited by third party
Title
Anonymous, "Genmab Announces Phase III Studies of Ofatumumab in Relapsing Multiple Sclerosis", https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-iii-studies-ofatumumab-relapsing-multiple/ , 2016/06/02; *
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)", NEUROLOGY, vol.82, https://n.neurology.org/content/82/10_Supplement/S23.006 , 2014/04/29; *
Bar-Or A et al., "The MIRROR Study: Treatment Phase Results for a Dose- Ranging Study of Ofatumumab in Subjects With Relapsing Remitting Multiple Sclerosis", https://ir.genmab.com/static-files/88c9172b-41c9-4102-9575-7f0097e19ee3 , 2014/04/29 *

Also Published As

Publication number Publication date
FI3733712T3 (fi) 2023-08-22
EP4252847A3 (en) 2023-11-15
CN120053639A (zh) 2025-05-30
EP4371611A3 (en) 2024-07-24
MX388593B (es) 2025-03-20
IL313932A (en) 2024-08-01
RS60807B1 (sr) 2020-10-30
CA3030530A1 (en) 2018-02-22
SI3497132T1 (sl) 2020-10-30
CY1123350T1 (el) 2021-12-31
PT3733712T (pt) 2023-08-31
AU2020201112B2 (en) 2021-07-22
IL276890B1 (en) 2023-06-01
MX2019001860A (es) 2019-07-08
AU2017311664B2 (en) 2020-01-02
PL3497132T3 (pl) 2020-11-30
RU2021105514A (ru) 2021-04-19
RU2019107146A3 (cg-RX-API-DMAC7.html) 2020-09-15
EP3733712B1 (en) 2023-05-24
US20250289902A1 (en) 2025-09-18
ES2821924T3 (es) 2021-04-28
TW201808333A (zh) 2018-03-16
US11161909B2 (en) 2021-11-02
DE202017007542U1 (de) 2022-07-19
JP6851391B2 (ja) 2021-03-31
PT3497132T (pt) 2020-09-25
IL276890A (en) 2020-10-29
HUE051948T2 (hu) 2021-03-29
AU2020201112A1 (en) 2020-03-05
JP2020100630A (ja) 2020-07-02
AU2017311664A1 (en) 2019-01-31
CN120037367A (zh) 2025-05-27
IL302488B2 (en) 2024-12-01
RS64541B1 (sr) 2023-09-29
CN120000782A (zh) 2025-05-16
AU2017311664C1 (en) 2025-05-22
JP2019511506A (ja) 2019-04-25
HRP20201388T1 (hr) 2020-11-27
LT3497132T (lt) 2020-10-12
US20190177424A1 (en) 2019-06-13
EP3497132A1 (en) 2019-06-19
RU2749951C2 (ru) 2021-06-21
EP4371611A2 (en) 2024-05-22
HUE063625T2 (hu) 2024-01-28
RU2021105514A3 (cg-RX-API-DMAC7.html) 2022-02-08
US20240150485A1 (en) 2024-05-09
JP7198786B2 (ja) 2023-01-04
LT3733712T (lt) 2023-09-11
CN120053638A (zh) 2025-05-30
RU2019107146A (ru) 2020-09-15
KR20200136503A (ko) 2020-12-07
DK3733712T3 (da) 2023-08-21
WO2018033841A1 (en) 2018-02-22
US20240317878A1 (en) 2024-09-26
CN109641965A (zh) 2019-04-16
AU2020201112C1 (en) 2025-05-22
CA3030530C (en) 2021-02-23
IL276890B2 (en) 2023-10-01
US12338290B2 (en) 2025-06-24
CA3101514A1 (en) 2018-02-22
IL264804B (en) 2020-09-30
HRP20230894T1 (hr) 2023-11-24
US20220081488A1 (en) 2022-03-17
IL302488B1 (en) 2024-08-01
EP3733712A1 (en) 2020-11-04
PL3733712T3 (pl) 2023-10-16
EP3497132B1 (en) 2020-06-24
EP4252847A2 (en) 2023-10-04
ES2954259T3 (es) 2023-11-21
DK3497132T3 (da) 2020-09-07
IL302488A (en) 2023-06-01
SI3733712T1 (sl) 2023-12-29
KR20190038914A (ko) 2019-04-09

Similar Documents

Publication Publication Date Title
US12338290B2 (en) Regimens and methods of treating multiple sclerosis using ofatumumab
RU2782069C2 (ru) Схемы и способы лечения рассеянного склероза с применением офатумумаба
HK40111448A (en) Regimens and methods of treating multiple sclerosis using ofatumumab
HK40101642A (en) Regimens and methods of treating multiple sclerosis using ofatumumab
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