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 PDFInfo
- 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
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- 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
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Classifications
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- 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
- C07K2317/90—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)
- 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)
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)
| 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)
| 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)
| 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 |
-
2021
- 2021-07-08 JP JP2023501079A patent/JP2023533030A/ja active Pending
- 2021-07-08 EP EP23193515.6A patent/EP4295905A1/en active Pending
- 2021-07-08 US US18/011,807 patent/US20230235035A1/en active Pending
- 2021-07-08 EP EP21748759.4A patent/EP4178674A1/en not_active Withdrawn
- 2021-07-08 WO PCT/US2021/040802 patent/WO2022011086A1/en not_active Ceased
Patent Citations (1)
| 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 |
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| EA043233B1 (ru) | ДОЗИРОВАНИЕ И ВВЕДЕНИЕ АНТИТЕЛ ПРОТИВ C5 ДЛЯ ЛЕЧЕНИЯ ПАЦИЕНТОВ С ПАРОКСИЗМАЛЬНОЙ НОЧНОЙ ГЕМОГЛОБИНУРИЕЙ (PNH) И АТИПИЧНЫМ ГЕМОЛИТИКО-УРЕМИЧЕСКИМ СИНДРОМОМ (aHUS) |
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