JP2022520107A - 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与 - Google Patents

全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与 Download PDF

Info

Publication number
JP2022520107A
JP2022520107A JP2021547420A JP2021547420A JP2022520107A JP 2022520107 A JP2022520107 A JP 2022520107A JP 2021547420 A JP2021547420 A JP 2021547420A JP 2021547420 A JP2021547420 A JP 2021547420A JP 2022520107 A JP2022520107 A JP 2022520107A
Authority
JP
Japan
Prior art keywords
antibody
treatment
antigen
weeks
patient
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.)
Withdrawn
Application number
JP2021547420A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022520107A5 (enExample
Inventor
ケンジ フジタ,
ニシ ランパル,
ウェイ-ジアン パン,
カウシック パトラ,
Original Assignee
アレクシオン ファーマシューティカルズ, インコーポレイテッド
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 アレクシオン ファーマシューティカルズ, インコーポレイテッド filed Critical アレクシオン ファーマシューティカルズ, インコーポレイテッド
Publication of JP2022520107A publication Critical patent/JP2022520107A/ja
Publication of JP2022520107A5 publication Critical patent/JP2022520107A5/ja
Priority to JP2025051765A priority Critical patent/JP2025092553A/ja
Withdrawn legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04—Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Genetics & Genomics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2021547420A 2019-02-14 2020-02-13 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与 Withdrawn JP2022520107A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025051765A JP2025092553A (ja) 2019-02-14 2025-03-26 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962805350P 2019-02-14 2019-02-14
US62/805,350 2019-02-14
US201962814935P 2019-03-07 2019-03-07
US62/814,935 2019-03-07
PCT/US2020/018113 WO2020168079A1 (en) 2019-02-14 2020-02-13 Dosage and administration of anti-c5 antibodies for treatment of generalized myasthenia gravis

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025051765A Division JP2025092553A (ja) 2019-02-14 2025-03-26 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与

Publications (2)

Publication Number Publication Date
JP2022520107A true JP2022520107A (ja) 2022-03-28
JP2022520107A5 JP2022520107A5 (enExample) 2023-02-20

Family

ID=69954108

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021547420A Withdrawn JP2022520107A (ja) 2019-02-14 2020-02-13 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与
JP2025051765A Pending JP2025092553A (ja) 2019-02-14 2025-03-26 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025051765A Pending JP2025092553A (ja) 2019-02-14 2025-03-26 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与

Country Status (9)

Country Link
US (2) US20200331993A1 (enExample)
EP (1) EP3924380A1 (enExample)
JP (2) JP2022520107A (enExample)
KR (2) KR20260046520A (enExample)
CN (2) CN113614106A (enExample)
AU (1) AU2020223298A1 (enExample)
CA (1) CA3130300A1 (enExample)
MX (1) MX2021009789A (enExample)
WO (1) WO2020168079A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3024618A1 (en) 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
US12620484B2 (en) 2020-08-24 2026-05-05 Nvidia Corporation Machine-learning techniques for oxygen therapy prediction using medical imaging data and clinical metadata
CA3173016A1 (en) * 2021-01-22 2022-07-28 Gin-Fu CHEN Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody
EP4370547A1 (en) * 2021-07-14 2024-05-22 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of myasthenia gravis

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017512463A (ja) * 2014-03-07 2017-05-25 アレクシオン ファーマシューティカルズ, インコーポレイテッド 向上した薬物動態を有する抗c5抗体
WO2017205101A1 (en) * 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
WO2019023564A1 (en) * 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
US20160168237A1 (en) * 2014-12-12 2016-06-16 Alexion Pharmaceuticals, Inc. Method for treating a complement mediated disorder caused by an infectious agent in a patient
EA201791366A1 (ru) 2014-12-19 2018-02-28 Чугаи Сейяку Кабусики Кайся Антитела к c5 и способы их применения
IL263481B2 (en) 2016-06-14 2024-06-01 Regeneron Pharma Anti-c5 antibodies and uses thereof
JP7518764B2 (ja) * 2017-10-26 2024-07-18 アレクシオン ファーマシューティカルズ, インコーポレイテッド 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017512463A (ja) * 2014-03-07 2017-05-25 アレクシオン ファーマシューティカルズ, インコーポレイテッド 向上した薬物動態を有する抗c5抗体
WO2017205101A1 (en) * 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
WO2019023564A1 (en) * 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"NCT02949128 Version 1: 2016-10-27", CLINICALTRIALS.GOV [ONLINE], JPN6024004469, 27 October 2016 (2016-10-27), ISSN: 0005468574 *

Also Published As

Publication number Publication date
CN119326881A (zh) 2025-01-21
WO2020168079A1 (en) 2020-08-20
KR20260046520A (ko) 2026-04-07
AU2020223298A1 (en) 2021-09-02
KR20210126045A (ko) 2021-10-19
EP3924380A1 (en) 2021-12-22
JP2025092553A (ja) 2025-06-19
US20200331993A1 (en) 2020-10-22
US20250243264A1 (en) 2025-07-31
MX2021009789A (es) 2021-11-17
CN113614106A (zh) 2021-11-05
CA3130300A1 (en) 2020-08-20

Similar Documents

Publication Publication Date Title
JP2025092553A (ja) 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与
JP2022512632A (ja) 発作性夜間ヘモグロビン尿症(pnh)の処置のための抗c5抗体の皮下投薬及び投与
JP2021501134A (ja) 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP2023533682A (ja) 補体関連病態の処置用抗c5抗体の皮下(sc)投与
JP2025084932A (ja) 視神経脊髄炎スペクトラム障害の治療のための抗c5抗体
US20260022164A1 (en) Compositions and methods for the treatment of neuromyelitis optica spectrum disorder
JP2021501213A (ja) IgE介在アレルギー性疾患の治療
JP2024521474A (ja) 皮膚筋炎(dm)を治療するための抗c5抗体の投与量及び投与
JP2023539047A (ja) 造血幹細胞移植関連血栓性微小血管症(hsct-tma)を処置するための抗c5抗体の用量及び投与
US20250154232A1 (en) Dosage and administration of anti-c5 antibodies for treatment of myasthenia gravis
JP2025518796A (ja) 重症筋無力症の治療のための融合ポリペプチドの投薬量及び投与
Fick IgE and anti-IgE therapy in asthma and allergic disease
KR20240004367A (ko) 중증근무력증 치료를 위한 항-cd19 항체의 사용
EA046524B1 (ru) Доза и введение антител к c5 для лечения генерализованной миастении гравис
WO2021263056A1 (en) Dosage and administration of anti-c5 antibodies for treatment of amyotrophic lateral sclerosis
JP2026515940A (ja) 補体障害の治療のための抗c5抗体の小児投与量及び投与
EA050729B1 (ru) Антитело к с5 для лечения нейромиелита зрительного нерва со спектральным расстройством

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230210

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20230210

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20240131

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240202

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240501

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240628

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240802

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20241126

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250326

A761 Written withdrawal of application

Free format text: JAPANESE INTERMEDIATE CODE: A761

Effective date: 20250411