JP7689141B2 - 高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 - Google Patents
高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 Download PDFInfo
- Publication number
- JP7689141B2 JP7689141B2 JP2022556091A JP2022556091A JP7689141B2 JP 7689141 B2 JP7689141 B2 JP 7689141B2 JP 2022556091 A JP2022556091 A JP 2022556091A JP 2022556091 A JP2022556091 A JP 2022556091A JP 7689141 B2 JP7689141 B2 JP 7689141B2
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical formulation
- concentration
- arginine
- histidine
- ban2401
- 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
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/133—Amines having hydroxy groups, e.g. sphingosine
-
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Cosmetics (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2025064827A JP2025111516A (ja) | 2020-03-20 | 2025-04-10 | 高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062992746P | 2020-03-20 | 2020-03-20 | |
| US62/992,746 | 2020-03-20 | ||
| US202063027263P | 2020-05-19 | 2020-05-19 | |
| US63/027,263 | 2020-05-19 | ||
| PCT/IB2021/000155 WO2021186245A1 (en) | 2020-03-20 | 2021-03-19 | HIGH CONCENTRATION ANTI-Aß PROTOFIBRIL ANTIBODY FORMULATIONS AND METHODS OF USE THEREOF |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2025064827A Division JP2025111516A (ja) | 2020-03-20 | 2025-04-10 | 高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2023518066A JP2023518066A (ja) | 2023-04-27 |
| JP2023518066A5 JP2023518066A5 (https=) | 2024-10-08 |
| JP7689141B2 true JP7689141B2 (ja) | 2025-06-05 |
Family
ID=75746958
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022556091A Active JP7689141B2 (ja) | 2020-03-20 | 2021-03-19 | 高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 |
| JP2025064827A Pending JP2025111516A (ja) | 2020-03-20 | 2025-04-10 | 高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2025064827A Pending JP2025111516A (ja) | 2020-03-20 | 2025-04-10 | 高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 |
Country Status (27)
| Country | Link |
|---|---|
| US (1) | US20230183328A1 (https=) |
| EP (2) | EP4121007B1 (https=) |
| JP (2) | JP7689141B2 (https=) |
| KR (1) | KR20220156534A (https=) |
| CN (1) | CN115315251A (https=) |
| AU (1) | AU2021238951A1 (https=) |
| BR (1) | BR112022018766A2 (https=) |
| CA (1) | CA3174778A1 (https=) |
| CL (2) | CL2022002517A1 (https=) |
| CO (1) | CO2022012916A2 (https=) |
| DK (1) | DK4121007T3 (https=) |
| ES (1) | ES3041762T3 (https=) |
| FI (1) | FI4121007T3 (https=) |
| HR (1) | HRP20251087T1 (https=) |
| HU (1) | HUE072937T2 (https=) |
| IL (2) | IL295383B1 (https=) |
| LT (1) | LT4121007T (https=) |
| MA (1) | MA59082B1 (https=) |
| MD (1) | MD4121007T2 (https=) |
| MX (1) | MX2022011101A (https=) |
| PH (1) | PH12022552172A1 (https=) |
| PL (1) | PL4121007T3 (https=) |
| PT (1) | PT4121007T (https=) |
| RS (1) | RS67249B1 (https=) |
| SI (1) | SI4121007T1 (https=) |
| SM (1) | SMT202500350T1 (https=) |
| WO (1) | WO2021186245A1 (https=) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20230039734A (ko) | 2020-07-23 | 2023-03-21 | 오타이르 프로테나 리미티드 | 항-Aβ 항체 |
| AU2022307687A1 (en) | 2021-07-09 | 2024-01-04 | Eisai R&D Management Co., Ltd. | Biomarkers for alzheimer's disease treatment |
| AU2022439338A1 (en) | 2022-02-02 | 2024-08-15 | Eisai R&D Management Co., Ltd. | Methods of treatment using p-tau181 level |
| JP2025539394A (ja) | 2022-11-28 | 2025-12-05 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | タウｐｅｔレベルを使用する治療の方法 |
| KR20260022396A (ko) | 2023-06-09 | 2026-02-19 | 에자이 알앤드디 매니지먼트 가부시키가이샤 | 항-Aβ 프로토피브릴 항체를 사용한 치료 방법 |
| WO2026015877A1 (en) | 2024-07-12 | 2026-01-15 | Eisai R&D Management Co., Ltd. | Fluid biomarker |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| CN118370815A (zh) | 2017-08-22 | 2024-07-23 | 渤健马萨诸塞州股份有限公司 | 含有抗β淀粉样蛋白抗体的药物组合物 |
| US20210324056A1 (en) | 2018-07-24 | 2021-10-21 | Eisai R&D Management Co., Ltd. | Methods of treatment and prevention of alzheimer's disease |
-
2021
- 2021-03-19 RS RS20250922A patent/RS67249B1/sr unknown
- 2021-03-19 EP EP21722538.2A patent/EP4121007B1/en active Active
- 2021-03-19 BR BR112022018766A patent/BR112022018766A2/pt unknown
- 2021-03-19 KR KR1020227030919A patent/KR20220156534A/ko active Pending
- 2021-03-19 PL PL21722538.2T patent/PL4121007T3/pl unknown
- 2021-03-19 MX MX2022011101A patent/MX2022011101A/es unknown
- 2021-03-19 IL IL295383A patent/IL295383B1/en unknown
- 2021-03-19 FI FIEP21722538.2T patent/FI4121007T3/fi active
- 2021-03-19 WO PCT/IB2021/000155 patent/WO2021186245A1/en not_active Ceased
- 2021-03-19 CN CN202180019180.6A patent/CN115315251A/zh active Pending
- 2021-03-19 PH PH1/2022/552172A patent/PH12022552172A1/en unknown
- 2021-03-19 AU AU2021238951A patent/AU2021238951A1/en active Pending
- 2021-03-19 US US17/906,660 patent/US20230183328A1/en active Pending
- 2021-03-19 MD MDE20230104T patent/MD4121007T2/ro unknown
- 2021-03-19 SI SI202130347T patent/SI4121007T1/sl unknown
- 2021-03-19 PT PT217225382T patent/PT4121007T/pt unknown
- 2021-03-19 IL IL326613A patent/IL326613A/en unknown
- 2021-03-19 DK DK21722538.2T patent/DK4121007T3/da active
- 2021-03-19 EP EP23179487.6A patent/EP4252777A3/en active Pending
- 2021-03-19 SM SM20250350T patent/SMT202500350T1/it unknown
- 2021-03-19 JP JP2022556091A patent/JP7689141B2/ja active Active
- 2021-03-19 HU HUE21722538A patent/HUE072937T2/hu unknown
- 2021-03-19 LT LTEPPCT/IB2021/000155T patent/LT4121007T/lt unknown
- 2021-03-19 MA MA59082A patent/MA59082B1/fr unknown
- 2021-03-19 HR HRP20251087TT patent/HRP20251087T1/hr unknown
- 2021-03-19 CA CA3174778A patent/CA3174778A1/en active Pending
- 2021-03-19 ES ES21722538T patent/ES3041762T3/es active Active
-
2022
- 2022-09-12 CO CONC2022/0012916A patent/CO2022012916A2/es unknown
- 2022-09-14 CL CL2022002517A patent/CL2022002517A1/es unknown
-
2024
- 2024-11-08 CL CL2024003428A patent/CL2024003428A1/es unknown
-
2025
- 2025-04-10 JP JP2025064827A patent/JP2025111516A/ja active Pending
Non-Patent Citations (2)
| Title |
|---|
| Dheeraj S. Tomar et al.，Molecular basis of high viscosity in concentrated antibody solutions: Strategies for high concentration drug product development，mAbs，2016年，Vol.8, No.2，Pages 216-228 |
| Yoann Le Basle et al，Physicochemical Stability of Monoclonal Antibodies: A Review，Journal of Pharmaceutical Sciences，2020年01月，Vol.109, No.1，Pages 169-190 |
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP7689141B2 (ja) | 高濃度抗Ａβプロトフィブリル抗体製剤及びその使用方法 | |
| JP2021105033A (ja) | 高度に濃縮された低粘度のｍａｓｐ−２阻害抗体製剤、キット、および方法 | |
| US20260108611A1 (en) | Formulations with reduced degradation of polysorbate | |
| CN113453719A (zh) | 包含抗cd47抗体的制剂及其制备方法和用途 | |
| CN114146174B (zh) | 抗pd-l1/ox40双特异性抗体制剂及其制备方法和用途 | |
| WO2022017468A1 (zh) | Pd-l1/lag-3双特异性抗体制剂及其制备方法和用途 | |
| WO2023061424A1 (en) | Pharmaceutical formulation comprising anti-ox40 monoclonal antibody | |
| JP2020531523A (ja) | 高度に濃縮された低粘度のｍａｓｐ−２阻害抗体製剤、キット、および非定型溶血性症候群に罹患した対象の治療方法 | |
| RU2846725C1 (ru) | ВЫСОКОКОНЦЕНТРИРОВАННЫЕ СОСТАВЫ НА ОСНОВЕ АНТИТЕЛ К ПРОТОФИБРИЛЛАМ Аβ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ | |
| KR20240100493A (ko) | 항-cd22 항체의 수성 제제 및 이의 용도 | |
| KR20230020449A (ko) | 레빌리맙의 수성 약학적 조성물 | |
| HK40102754A (en) | High concentration anti-ass protofibril antibody formulations and methods of use thereof | |
| EP4434517A1 (en) | Anti-sost antibody pharmaceutical composition and use thereof | |
| HK40085437A (en) | High concentration anti-amyloid beta peptide protofibril antibody formulations and methods of use thereof | |
| HK40085437B (en) | High concentration anti-amyloid beta peptide protofibril antibody formulations and methods of use thereof | |
| BR122025027938A2 (pt) | FORMULAÇÕES DE ANTICORPO DE PROTOFIBRILA ANTI-Abeta DE CONCENTRAÇÃO ALTA E MÉTODOS DE USO DAS MESMAS | |
| TW202525341A (zh) | 穩定的液體調配物 | |
| WO2025255300A1 (en) | FORMULATIONS FOR ANTI-N3pGlu AMYLOID BETA ANTIBODIES | |
| JP2025534054A (ja) | 抗ｔｉｇｉｔ抗体を含む製剤及びその使用方法 | |
| WO2026085262A1 (en) | Liquid pharmaceutical formulations for an anti-il-1beta antibody | |
| EA045933B1 (ru) | Водная фармацевтическая композиция левилимаба и ее применение | |
| HK40059591A (en) | Preparations containing anti-cd47 antibody, and preparation method and use therefor |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20231010 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20240930 |
|
| A871 | Explanation of circumstances concerning accelerated examination |
Free format text: JAPANESE INTERMEDIATE CODE: A871 Effective date: 20240930 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20241001 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20241008 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20241209 |
|
| A02 | Decision of refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A02 Effective date: 20250114 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20250410 |
|
| TRDD | Decision of grant or rejection written | ||
| A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20250520 |
|
| A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20250526 |
|
| R150 | Certificate of patent or registration of utility model |
Ref document number: 7689141 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |