JP6953433B2 - Vegfアンタゴニストを含む液体医薬組成物および同医薬組成物を含有する充填済みシリンジ - Google Patents

Vegfアンタゴニストを含む液体医薬組成物および同医薬組成物を含有する充填済みシリンジ Download PDF

Info

Publication number
JP6953433B2
JP6953433B2 JP2018557209A JP2018557209A JP6953433B2 JP 6953433 B2 JP6953433 B2 JP 6953433B2 JP 2018557209 A JP2018557209 A JP 2018557209A JP 2018557209 A JP2018557209 A JP 2018557209A JP 6953433 B2 JP6953433 B2 JP 6953433B2
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
histidine
concentration
aflibercept
composition according
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
Application number
JP2018557209A
Other languages
English (en)
Japanese (ja)
Other versions
JP2019504882A5 (enExample
JP2019504882A (ja
Inventor
ジーグル、ライナー
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Formycon AG
Original Assignee
Formycon AG
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 Formycon AG filed Critical Formycon AG
Publication of JP2019504882A publication Critical patent/JP2019504882A/ja
Publication of JP2019504882A5 publication Critical patent/JP2019504882A5/ja
Application granted granted Critical
Publication of JP6953433B2 publication Critical patent/JP6953433B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • A61K9/0051Ocular inserts, ocular implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/10Ophthalmic agents for accommodation disorders, e.g. myopia
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2018557209A 2016-01-26 2017-01-26 Vegfアンタゴニストを含む液体医薬組成物および同医薬組成物を含有する充填済みシリンジ Active JP6953433B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP16152767 2016-01-26
EP16152767.6 2016-01-26
EP16199497 2016-11-18
EP16199497.5 2016-11-18
PCT/EP2017/051662 WO2017129685A1 (en) 2016-01-26 2017-01-26 Liquid formulation of a vegf antagonist

Publications (3)

Publication Number Publication Date
JP2019504882A JP2019504882A (ja) 2019-02-21
JP2019504882A5 JP2019504882A5 (enExample) 2019-12-12
JP6953433B2 true JP6953433B2 (ja) 2021-10-27

Family

ID=57882094

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2018557209A Active JP6953433B2 (ja) 2016-01-26 2017-01-26 Vegfアンタゴニストを含む液体医薬組成物および同医薬組成物を含有する充填済みシリンジ

Country Status (6)

Country Link
US (3) US10576128B2 (enExample)
EP (1) EP3407868A1 (enExample)
JP (1) JP6953433B2 (enExample)
AU (1) AU2017213103B2 (enExample)
CA (1) CA3011638C (enExample)
WO (1) WO2017129685A1 (enExample)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7608261B2 (en) 2006-06-16 2009-10-27 Regeneron Pharmacuticals, Inc. VEGF antagonist formulations suitable for intravitreal administration
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
EP3518971A4 (en) * 2016-09-28 2020-05-13 Board Of Regents, The University Of Texas System Antibody and protein therapeutic formulations and uses thereof
JP7116059B2 (ja) * 2016-11-21 2022-08-09 ジャスト-エヴォテック バイオロジックス、インコーポレイテッド アフリベルセプト製剤及びその使用
KR20230079456A (ko) 2017-03-27 2023-06-07 리제너론 파아마슈티컬스, 인크. 살균 방법
WO2019020777A1 (en) 2017-07-26 2019-01-31 Formycon Ag LIQUID FORMULATION OF A VEGF ANTAGONIST
US20200255496A1 (en) 2017-09-18 2020-08-13 Amgen Inc. Vegfr-fc fusion protein formulations
CA3082899A1 (en) * 2017-11-17 2019-05-23 Amgen Inc. Vegfr-fc fusion protein formulations
CN111356471A (zh) * 2017-11-20 2020-06-30 济世发展生物药业有限公司 包含赖氨酸盐作为张力调节剂的阿柏西普制剂及其用途
IL318714A (en) * 2018-05-10 2025-03-01 Regeneron Pharma Formulations that include high concentrations of VEGF receptor fusion protein
CA3100038A1 (en) * 2018-08-30 2020-03-05 Regeneron Pharmaceuticals, Inc. Methods for characterizing protein complexes
EP3851096A4 (en) * 2018-09-10 2022-07-06 Samsung Bioepis Co., Ltd. LIQUID COMPOSITION COMPRISING A PROTEIN
EP3870145A1 (en) 2018-10-26 2021-09-01 Amgen Inc. Formulations comprising a tris buffer and a protein
MX2021004774A (es) * 2018-10-29 2021-08-24 Hoffmann La Roche Formulacion de anticuerpos.
JP7266108B2 (ja) 2019-02-18 2023-04-27 イーライ リリー アンド カンパニー 治療用抗体製剤
MY190623A (en) 2019-12-06 2022-04-27 Regeneron Pharma Anti-vegf protein compositions and methods for producing the same
AU2021232369B2 (en) * 2020-03-04 2025-06-05 Shanghai Henlius Biotech, Inc. Pharmaceutical formulation comprising bevacizumab
CN115803009A (zh) 2020-05-08 2023-03-14 瑞泽恩制药公司 用于治疗眼病和癌症的vegf阱和微阱及方法
KR20220015976A (ko) * 2020-07-31 2022-02-08 (주)셀트리온 안정한 약제학적 제제
US11723955B1 (en) 2022-05-13 2023-08-15 Allgenesis Biotherapeutics Inc. VEGFR fusion protein pharmaceutical composition
WO2025217334A1 (en) * 2024-04-09 2025-10-16 Regeneron Pharmaceuticals, Inc. Low concentration vegf receptor fusion protein containing formulations

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6124449A (en) 1990-06-11 2000-09-26 Nexstar Pharmaceuticals, Inc. High affinity TGFβ nucleic acid ligands and inhibitors
US5731144A (en) 1990-06-11 1998-03-24 Nexstar Pharmaceuticals, Inc. High affinity TGFβ nucleic acid ligands
US5731424A (en) 1990-06-11 1998-03-24 Nexstar Pharmaceuticals, Inc. High affinity TGFβ nucleic acid ligands and inhibitors
US6582959B2 (en) 1991-03-29 2003-06-24 Genentech, Inc. Antibodies to vascular endothelial cell growth factor
DK1167384T3 (da) 1992-10-28 2007-04-10 Genentech Inc Vaskular endotheliel cellevækstfaktor antagonister
IL117645A (en) 1995-03-30 2005-08-31 Genentech Inc Vascular endothelial cell growth factor antagonists for use as medicaments in the treatment of age-related macular degeneration
EP1741780A3 (en) 1995-06-02 2007-03-28 Gilead Sciences, Inc. High affinity oligonucleotide ligands to growth factors
PT1695985E (pt) 1997-04-07 2011-06-06 Genentech Inc Métodos para formar anticorpos humanizados por mutagénese aleatória
US20020032315A1 (en) 1997-08-06 2002-03-14 Manuel Baca Anti-vegf antibodies
DK1325932T5 (da) 1997-04-07 2005-10-03 Genentech Inc Anti-VEGF antistoffer
US6703020B1 (en) 1999-04-28 2004-03-09 Board Of Regents, The University Of Texas System Antibody conjugate methods for selectively inhibiting VEGF
HU230159B1 (hu) 1999-06-08 2015-09-28 Regeneron Pharmaceuticals, Inc. VEGF receptor kimérák alkalmazása vaszkuláris permeabilitással jellemzett szembetegség kezelésére
WO2005044853A2 (en) 2003-11-01 2005-05-19 Genentech, Inc. Anti-vegf antibodies
PL1861116T3 (pl) 2005-03-25 2016-02-29 Regeneron Pharma Formulacje antagonistów VEGF
US7608261B2 (en) * 2006-06-16 2009-10-27 Regeneron Pharmacuticals, Inc. VEGF antagonist formulations suitable for intravitreal administration
EP3219294A1 (en) * 2006-06-20 2017-09-20 Ben-Gurion University of The Negev Research and Development Authority Amphiphilic peptides and hydrogel matrices thereof for bone repair
KR101737466B1 (ko) 2008-06-25 2017-05-18 에스바테크 - 어 노바티스 컴파니 엘엘씨 Vegf를 억제하는 안정하고 가용성인 항체
CN102272148A (zh) 2008-11-03 2011-12-07 分子组合公司 抑制vegf-a受体相互作用的结合蛋白
TWI510246B (zh) 2010-04-30 2015-12-01 Molecular Partners Ag 抑制vegf-a受體交互作用的經修飾結合性蛋白質
US20130323242A1 (en) * 2012-06-01 2013-12-05 Ophthotech Corp. Compositions comprising an anti-pdgf aptamer and a vegf antagonist
EA201492289A1 (ru) * 2012-06-01 2015-05-29 Офтотек Корпорейшн Композиции, содержащие аптамер против pdgf и антагонист vegf
EP2890389A1 (en) * 2012-08-28 2015-07-08 Novartis AG Use of a vegf antagonist in treating ocular vascular proliferative diseases
WO2014203182A1 (en) * 2013-06-20 2014-12-24 Novartis Ag Use of a vegf antagonist in treating choroidal neovascularisation
ES2875878T3 (es) 2013-11-18 2021-11-11 Formycon Ag Composición farmacéutica de un anticuerpo anti-VEGF
RU2702748C2 (ru) 2014-05-12 2019-10-11 Формикон Аг Предварительно заполненный пластиковый шприц, содержащий антагонист vegf
KR101808234B1 (ko) * 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
RU2018121813A (ru) 2015-11-18 2019-12-19 Формикон Аг Предварительно заполненный пластиковый шприц, содержащий антагонист vegf

Also Published As

Publication number Publication date
CA3011638C (en) 2023-01-10
WO2017129685A1 (en) 2017-08-03
CA3011638A1 (en) 2017-08-03
EP3407868A1 (en) 2018-12-05
AU2017213103A1 (en) 2018-07-26
US10576128B2 (en) 2020-03-03
US20190030123A1 (en) 2019-01-31
AU2017213103B2 (en) 2022-08-11
US20230248806A1 (en) 2023-08-10
US20200237862A1 (en) 2020-07-30
JP2019504882A (ja) 2019-02-21

Similar Documents

Publication Publication Date Title
JP6953433B2 (ja) Vegfアンタゴニストを含む液体医薬組成物および同医薬組成物を含有する充填済みシリンジ
JP2022177129A (ja) Vegf拮抗薬を収容したプレフィルドプラスチックシリンジ
EP3071181B1 (en) Pharmaceutical composition of an anti-vegf antibody
AU2007238677B2 (en) Use of IL-I antibodies for treating ophthalmic disorders
WO2019020777A1 (en) LIQUID FORMULATION OF A VEGF ANTAGONIST
JP2010512356A (ja) 非経口aベータ抗体製剤
EP2473191A1 (en) Antibody coformulations
KR20210062027A (ko) Csf-1r 항체 제제
TR201909584T4 (tr) İşlenmiş anti-IL-23p19 antikorların solüsyon formülasyonları.
CN114340674A (zh) 抗-IL-23p19抗体制剂
JP2023535433A (ja) Pd-l1/lag-3二重特異性抗体製剤およびその調製方法ならびに使用
KR20240053633A (ko) Vegf 수용체 융합 단백질을 위한 제제
KR20210029789A (ko) 고농도 액체 항체 제형
CN111110841A (zh) 含有抗pcsk9抗体的稳定制剂
KR20210077645A (ko) 신규 주사제 제형
CN116077646B (zh) 一种抗冠状病毒s蛋白的抗体制剂及其制备方法和用途
CN116688115B (zh) 一种PD-L1/TGF-β双功能融合蛋白制剂及其用途
EP3808777A1 (en) Stable liquid antibody formulations
RU2807524C2 (ru) Составы антител к rsv и способы их применения
RU2776850C2 (ru) Способы лечения глазных заболеваний
TW202523351A (zh) 抗體調配物
CN118119377A (zh) 制剂
EA045592B1 (ru) Жидкий препарат, содержащий антитело к il-17
HK40059591A (en) Preparations containing anti-cd47 antibody, and preparation method and use therefor
EA042435B1 (ru) Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20191101

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20191101

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20200930

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20201006

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20210105

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210317

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: 20210901

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20210929

R150 Certificate of patent or registration of utility model

Ref document number: 6953433

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250