JP7295038B2 - 小児患者のための生物薬剤組成物及び方法 - Google Patents
小児患者のための生物薬剤組成物及び方法 Download PDFInfo
- Publication number
- JP7295038B2 JP7295038B2 JP2019566881A JP2019566881A JP7295038B2 JP 7295038 B2 JP7295038 B2 JP 7295038B2 JP 2019566881 A JP2019566881 A JP 2019566881A JP 2019566881 A JP2019566881 A JP 2019566881A JP 7295038 B2 JP7295038 B2 JP 7295038B2
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- Japan
- Prior art keywords
- asthma
- antibody
- eosinophilic
- severe
- pediatric subject
- 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.)
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- 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
-
- 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
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- 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
-
- 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
- A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- 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
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2023094740A JP2023113883A (ja) | 2017-06-06 | 2023-06-08 | 小児患者のための生物薬剤組成物及び方法 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762515641P | 2017-06-06 | 2017-06-06 | |
| US62/515,641 | 2017-06-06 | ||
| US201862619206P | 2018-01-19 | 2018-01-19 | |
| US62/619,206 | 2018-01-19 | ||
| PCT/US2018/031518 WO2018226339A1 (en) | 2017-06-06 | 2018-05-08 | Biopharmaceutical compositions and methods for pediatric patients |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023094740A Division JP2023113883A (ja) | 2017-06-06 | 2023-06-08 | 小児患者のための生物薬剤組成物及び方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020522524A JP2020522524A (ja) | 2020-07-30 |
| JP2020522524A5 JP2020522524A5 (https=) | 2021-07-26 |
| JP7295038B2 true JP7295038B2 (ja) | 2023-06-20 |
Family
ID=64566261
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019566881A Active JP7295038B2 (ja) | 2017-06-06 | 2018-05-08 | 小児患者のための生物薬剤組成物及び方法 |
| JP2023094740A Pending JP2023113883A (ja) | 2017-06-06 | 2023-06-08 | 小児患者のための生物薬剤組成物及び方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023094740A Pending JP2023113883A (ja) | 2017-06-06 | 2023-06-08 | 小児患者のための生物薬剤組成物及び方法 |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US11390671B2 (https=) |
| EP (1) | EP3634467A4 (https=) |
| JP (2) | JP7295038B2 (https=) |
| CN (2) | CN119632921A (https=) |
| BR (1) | BR112019025736A2 (https=) |
| CA (1) | CA3064859A1 (https=) |
| WO (1) | WO2018226339A1 (https=) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA3064859A1 (en) * | 2017-06-06 | 2018-12-13 | Glaxosmithkline Llc | Biopharmaceutical compositions and methods for pediatric patients |
| KR20210145187A (ko) * | 2019-03-29 | 2021-12-01 | 지앙수 헨그루이 메디슨 컴퍼니 리미티드 | Il-5에 대한 항체를 함유하는 약학적 조성물 및 이의 용도 |
| ES3057414T3 (en) * | 2020-12-22 | 2026-03-02 | Glaxosmithkline Ip Dev Ltd | Interleukin 5 binding protein dosage regimen |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017033121A1 (en) | 2015-08-24 | 2017-03-02 | Glaxosmithkline Intellectual Property (No. 2) Limited | Biopharmaceutical compositions |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8800397D0 (en) | 1988-01-08 | 1988-02-10 | Sandoz Ltd | Improvements in/relating to organic compounds |
| ZA898322B (en) | 1988-11-03 | 1990-11-28 | Schering Corp | Method of preventing or reducing eosinophilia |
| US5096704A (en) | 1988-11-03 | 1992-03-17 | Schering Corporation | Method of treating eosinophilia |
| HU215180B (hu) | 1992-01-23 | 1998-10-28 | Merck Patent Gmbh. | Eljárás monomer és dimer antitest-fragment fúziós fehérjék előállítására |
| SG49597A1 (en) | 1992-02-06 | 1998-06-15 | Schering Corp | Design cloning and expression of humanized monoclonal antibodies against human interleukin-5 |
| JPH06141885A (ja) | 1992-11-05 | 1994-05-24 | Chemo Sero Therapeut Res Inst | モノクローナル抗体 |
| GB9412230D0 (en) | 1994-06-17 | 1994-08-10 | Celltech Ltd | Interleukin-5 specific recombiant antibodies |
| US5683892A (en) | 1994-12-23 | 1997-11-04 | Smithkline Beecham Corporation | DNA encoding recombinant IL-5 antagonists useful in treatment of IL-5 mediated disorders |
| US5783184A (en) | 1994-12-23 | 1998-07-21 | Smithkline Beecham Corporation | Method for treatment and diagnosis of IL-5 mediated disorders |
| US7399837B2 (en) | 1995-12-22 | 2008-07-15 | Smithkline Beecham Corporation | Recombinant IL-5 antagonists useful in treatment of IL-5 mediated disorders |
| US6248723B1 (en) | 1997-06-10 | 2001-06-19 | National Jewish Medical And Research Center | Method for treatment of inflammatory disease |
| US5858089A (en) | 1997-08-26 | 1999-01-12 | Martinovic; Zoran | Corn buttering tool |
| TR200001117T2 (tr) | 1997-10-22 | 2000-09-21 | Ponikau Jens | Mukozal dokudaki enflomasyonu önlemek ve tedavi etmek için maddeler ve yöntemler. |
| ES2327830T3 (es) | 2002-03-29 | 2009-11-04 | Schering Corporation | Anticuerpos monoclonales humanos anti-interleuquina-5 y metodos y composiciones que los contienen. |
| JP4597643B2 (ja) | 2004-11-24 | 2010-12-15 | 富士フイルム株式会社 | 電子内視鏡 |
| JP2010526088A (ja) | 2007-04-30 | 2010-07-29 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | 抗il−5抗体を投与するための方法 |
| US20090035216A1 (en) | 2007-08-03 | 2009-02-05 | Biomonitor Aps | Method for determining in vivo biopharmaceutical concentration or bioavailability |
| AU2008328726B2 (en) | 2007-11-30 | 2014-06-12 | Glaxo Group Limited | Antigen-binding constructs |
| JP5035153B2 (ja) | 2008-07-14 | 2012-09-26 | 市光工業株式会社 | 車両用灯具 |
| CN107837395A (zh) | 2011-02-09 | 2018-03-27 | 葛兰素史密斯克莱有限责任公司 | 冻干制剂 |
| CA2832560A1 (en) * | 2011-04-07 | 2012-10-18 | Glaxosmithkline Llc | Formulations with reduced viscosity |
| WO2014141149A1 (en) * | 2013-03-15 | 2014-09-18 | Glaxosmithkline Intellectual Property (No.2) Limited | Formulations with reduced viscosity |
| CA3064859A1 (en) * | 2017-06-06 | 2018-12-13 | Glaxosmithkline Llc | Biopharmaceutical compositions and methods for pediatric patients |
-
2018
- 2018-05-08 CA CA3064859A patent/CA3064859A1/en active Pending
- 2018-05-08 WO PCT/US2018/031518 patent/WO2018226339A1/en not_active Ceased
- 2018-05-08 BR BR112019025736-5A patent/BR112019025736A2/pt unknown
- 2018-05-08 CN CN202411850626.1A patent/CN119632921A/zh active Pending
- 2018-05-08 EP EP18814398.6A patent/EP3634467A4/en active Pending
- 2018-05-08 CN CN201880051204.4A patent/CN110913887A/zh active Pending
- 2018-05-08 JP JP2019566881A patent/JP7295038B2/ja active Active
- 2018-05-08 US US16/619,146 patent/US11390671B2/en active Active
-
2022
- 2022-06-08 US US17/835,321 patent/US12286472B2/en active Active
-
2023
- 2023-06-08 JP JP2023094740A patent/JP2023113883A/ja active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017033121A1 (en) | 2015-08-24 | 2017-03-02 | Glaxosmithkline Intellectual Property (No. 2) Limited | Biopharmaceutical compositions |
Non-Patent Citations (5)
| Title |
|---|
| Deeks, E. D.,Mepolizumab: A Review in Eosinophilic Asthma,BioDrugs,2016年,Vol.30, No.4,p.361-370,doi:10.1007/s40259-016-0182-5 |
| GSKの「ヌーカラ(R)皮下注用100mg」が厚生労働省より製造販売承認を取得,[online],グラクソ・スミスクライン株式会社,2016年03月28日,[retrieved on 2022.05.30] ,Retrieved from the Internet: <URL: https://jp.gsk.com/ja-jp/news/press-releases/20160328-nucala-approval-2/> |
| Ortega, H. G. et al.,Mepolizumab treatment in patients with severe eosinophilic asthma,The New England Journal of Medicine,2015年,Vol.371, No.13,p.1198-1207,doi:10.1056/NEJMoa1403290,[published correction appears in N Engl J Med. 2015 Apr 30;372(18):1777] |
| 大場 延浩 ほか,適応外使用医薬品における小児投与量の現状調査,医療薬学,2005年03月,第31巻, 第3号,p.179-185 |
| 日下 隆,適応外使用での小児への用法・用量設計 用法・用量設計の実際,薬局,2015年02月,第66巻, 第2号,p.245-250 |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2020522524A (ja) | 2020-07-30 |
| BR112019025736A2 (pt) | 2020-06-30 |
| WO2018226339A1 (en) | 2018-12-13 |
| US20200157206A1 (en) | 2020-05-21 |
| JP2023113883A (ja) | 2023-08-16 |
| US11390671B2 (en) | 2022-07-19 |
| CA3064859A1 (en) | 2018-12-13 |
| CN119632921A (zh) | 2025-03-18 |
| US20220380451A1 (en) | 2022-12-01 |
| EP3634467A4 (en) | 2021-07-28 |
| EP3634467A1 (en) | 2020-04-15 |
| US12286472B2 (en) | 2025-04-29 |
| CN110913887A (zh) | 2020-03-24 |
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