JP2023533030A - 小児患者において発作性夜間血色素尿症(pnh)を治療するための抗c5抗体の投薬量及び投与 - Google Patents

小児患者において発作性夜間血色素尿症(pnh)を治療するための抗c5抗体の投薬量及び投与 Download PDF

Info

Publication number
JP2023533030A
JP2023533030A JP2023501079A JP2023501079A JP2023533030A JP 2023533030 A JP2023533030 A JP 2023533030A JP 2023501079 A JP2023501079 A JP 2023501079A JP 2023501079 A JP2023501079 A JP 2023501079A JP 2023533030 A JP2023533030 A JP 2023533030A
Authority
JP
Japan
Prior art keywords
dose
antibody
patients
patient
less
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.)
Pending
Application number
JP2023501079A
Other languages
English (en)
Japanese (ja)
Other versions
JP2023533030A5 (https=
JPWO2022011086A5 (https=
Inventor
ロリ ペイトン,
スコット ティー. ロッティングハウス,
ラジェンドラ プラダーン,
ステファン オルティス,
雅代 小川
シャン ガオ,
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 JP2023533030A publication Critical patent/JP2023533030A/ja
Publication of JP2023533030A5 publication Critical patent/JP2023533030A5/ja
Publication of JPWO2022011086A5 publication Critical patent/JPWO2022011086A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • 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
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (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)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2023501079A 2020-07-09 2021-07-08 小児患者において発作性夜間血色素尿症(pnh)を治療するための抗c5抗体の投薬量及び投与 Pending JP2023533030A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063049768P 2020-07-09 2020-07-09
US63/049,768 2020-07-09
PCT/US2021/040802 WO2022011086A1 (en) 2020-07-09 2021-07-08 Dosage and administration of anti-c5 antibodies for treating paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients

Publications (3)

Publication Number Publication Date
JP2023533030A true JP2023533030A (ja) 2023-08-01
JP2023533030A5 JP2023533030A5 (https=) 2025-10-03
JPWO2022011086A5 JPWO2022011086A5 (https=) 2025-10-03

Family

ID=77127113

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023501079A Pending JP2023533030A (ja) 2020-07-09 2021-07-08 小児患者において発作性夜間血色素尿症(pnh)を治療するための抗c5抗体の投薬量及び投与

Country Status (4)

Country Link
US (1) US20230235035A1 (https=)
EP (2) EP4295905A1 (https=)
JP (1) JP2023533030A (https=)
WO (1) WO2022011086A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019517473A (ja) 2016-05-27 2019-06-24 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Alexion Pharmaceuticals, Inc. 難治性全身型重症筋無力症の処置のための方法
US12404320B2 (en) 2018-05-31 2025-09-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients
CN112996561A (zh) 2018-10-30 2021-06-18 亚力兄制药公司 用于治疗阵发性睡眠性血红蛋白尿症(pnh)的抗c5抗体的皮下剂量和施用
WO2024227120A1 (en) * 2023-04-27 2024-10-31 Alexion Pharmaceuticals, Inc. Systems and methods for monitoring quality of life (qol) features in pnh patients treated with complement pathway inhibitors
EP4705337A1 (en) * 2023-05-02 2026-03-11 Alexion Pharmaceuticals, Inc. Pediatric dosage and administration of anti-c5 antibodies for treatment of complement disorders

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019231983A1 (en) * 2018-05-31 2019-12-05 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients

Family Cites Families (5)

* 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
NZ631007A (en) 2014-03-07 2015-10-30 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
CN107207607B (zh) * 2014-12-19 2021-05-04 中外制药株式会社 抗-c5抗体及使用方法
ES2984352T3 (es) * 2016-06-14 2024-10-29 Regeneron Pharma Anticuerpos anti-C5 y usos de los mismos

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019231983A1 (en) * 2018-05-31 2019-12-05 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients

Also Published As

Publication number Publication date
US20230235035A1 (en) 2023-07-27
EP4178674A1 (en) 2023-05-17
WO2022011086A1 (en) 2022-01-13
EP4295905A1 (en) 2023-12-27

Similar Documents

Publication Publication Date Title
JP7520725B2 (ja) 小児患者における発作性夜間ヘモグロビン尿症(pnh)の治療のための抗c5抗体の用量および投与
JP7518764B2 (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
JP7577542B2 (ja) 小児患者における非典型溶血性尿毒症症候群(aHUS)の治療のための抗C5抗体の用量および投与
JP2023533030A (ja) 小児患者において発作性夜間血色素尿症(pnh)を治療するための抗c5抗体の投薬量及び投与
AU2024266818B2 (en) Dosage and administration of anti-C5 antibodies for treatment of atypical hemolytic uremic syndrome (aHUS)
US20250145700A1 (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
JP2019537547A (ja) 新規なcd47モノクローナル抗体およびこの使用
WO2017123636A1 (en) Dosage and administration of anti-c5 antibodies for treatment
JP2026026191A (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
HK40097452A (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
JP2025529317A (ja) 造血幹細胞移植関連血栓性微小血管症(hsct-tma)を治療するための抗c5抗体の補足的投薬及び投与
HK40055105A (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
HK40055105B (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
EA043233B1 (ru) ДОЗИРОВАНИЕ И ВВЕДЕНИЕ АНТИТЕЛ ПРОТИВ C5 ДЛЯ ЛЕЧЕНИЯ ПАЦИЕНТОВ С ПАРОКСИЗМАЛЬНОЙ НОЧНОЙ ГЕМОГЛОБИНУРИЕЙ (PNH) И АТИПИЧНЫМ ГЕМОЛИТИКО-УРЕМИЧЕСКИМ СИНДРОМОМ (aHUS)

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240704

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20240704

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20250620

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20250625

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20250925

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20251105

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20260304