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 (https=
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 or 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IG], 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Cell Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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
EP16199497.5 2016-11-18
EP16199497 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 (https=) 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 (https=)
EP (1) EP3407868A1 (https=)
JP (1) JP6953433B2 (https=)
AU (1) AU2017213103B2 (https=)
CA (1) CA3011638C (https=)
WO (1) WO2017129685A1 (https=)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2654510C (en) 2006-06-16 2015-03-17 Regeneron Pharmaceuticals, 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
US10576128B2 (en) 2016-01-26 2020-03-03 Formycon Ag Liquid formulation of a VEGF antagonist
EP3518971A4 (en) * 2016-09-28 2020-05-13 Board Of Regents, The University Of Texas System ANTIBODIES AND THERAPEUTIC PROTEIN 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
FI3600456T3 (fi) 2017-03-27 2023-10-26 Regeneron Pharma Sterilointimenetelmä
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
MX2020005170A (es) * 2017-11-17 2020-10-16 Amgen Inc Formulaciones de proteinas de fusion vegfr-fc.
MY202872A (en) * 2017-11-20 2024-05-28 Just Evotec Biologics Inc Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
DK4364724T3 (da) * 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
JP7511542B2 (ja) * 2018-08-30 2024-07-05 リジェネロン・ファーマシューティカルズ・インコーポレイテッド タンパク質複合体を特徴づけるための方法
WO2020055123A1 (ko) * 2018-09-10 2020-03-19 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
US20210353713A1 (en) 2018-10-26 2021-11-18 Amgen Inc. Formulations comprising a tris buffer and a protein
MY195550A (en) * 2018-10-29 2023-01-31 Hoffmann La Roche Antibody Formulation
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
EP3886946A1 (en) 2019-06-05 2021-10-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
SG11202110968VA (en) 2019-12-06 2021-10-28 Regeneron Pharma Anti-vegf protein compositions and methods for producing the same
IL296119A (en) * 2020-03-04 2022-11-01 Shanghai Henlius Biotech Inc Pharmaceutical formulation comprising bevacizumab
AU2021268026A1 (en) 2020-05-08 2023-01-19 Regeneron Pharmaceuticals, Inc. VEGF traps and mini-traps and methods for treating ocular disorders and cancer
CA3190325A1 (en) * 2020-07-31 2022-02-03 Celltrion Inc. Stable pharmaceutical preparation
US11723955B1 (en) 2022-05-13 2023-08-15 Allgenesis Biotherapeutics Inc. VEGFR fusion protein pharmaceutical composition
USD1120314S1 (en) 2022-11-30 2026-03-24 Regeneron Pharmaceuticals, Inc. Dose delivery device
WO2025217334A1 (en) * 2024-04-09 2025-10-16 Regeneron Pharmaceuticals, Inc. Low concentration vegf receptor fusion protein containing formulations

Family Cites Families (29)

* 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
US5731424A (en) 1990-06-11 1998-03-24 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
US6582959B2 (en) 1991-03-29 2003-06-24 Genentech, Inc. Antibodies to vascular endothelial cell growth factor
AU687727B2 (en) 1992-10-28 1998-03-05 Genentech Inc. Vascular endothelial cell growth factor antagonists
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
JP4531132B2 (ja) 1995-06-02 2010-08-25 ギリード・サイエンシズ・インコーポレーテッド 増殖因子に対する高親和性オリゴヌクレオチドリガンド
KR100816621B1 (ko) 1997-04-07 2008-03-24 제넨테크, 인크. 항-vegf 항체
PT971959E (pt) 1997-04-07 2006-05-31 Genentech Inc Anticorpos humanizados e metodos para formar anticorpos humanizados
US20020032315A1 (en) 1997-08-06 2002-03-14 Manuel Baca Anti-vegf antibodies
US6703020B1 (en) 1999-04-28 2004-03-09 Board Of Regents, The University Of Texas System Antibody conjugate methods for selectively inhibiting VEGF
CN101433715B (zh) 1999-06-08 2013-04-17 里珍纳龙药品有限公司 具有改善的药物动力学特性的修饰嵌合多肽
WO2005044853A2 (en) 2003-11-01 2005-05-19 Genentech, Inc. Anti-vegf antibodies
ES2633574T3 (es) 2005-03-25 2017-09-22 Regeneron Pharmaceuticals, Inc. Formulaciones de antagonistas de VEGF
CA2654510C (en) * 2006-06-16 2015-03-17 Regeneron Pharmaceuticals, Inc. Vegf antagonist formulations suitable for intravitreal administration
EP2446862B1 (en) * 2006-06-20 2017-08-09 Ben Gurion University Of The Negev Research And Development Authority Amphiphilic peptides and hydrogel matrices thereof for bone repair
EP2167127A1 (en) 2007-07-10 2010-03-31 F. Hoffmann-Roche AG Novel formulation
BRPI0914251B1 (pt) 2008-06-25 2022-07-19 Novartis Ag Imunoligante recombinante, seu fragmento de ligação ao antígeno, uso dos mesmos, e composição
BRPI0921469B1 (pt) 2008-11-03 2022-01-18 Molecular Partners Ag Proteínas de ligação que inibem a interação com o receptor de vegf-a, composição farmacêutica
AR081361A1 (es) 2010-04-30 2012-08-29 Molecular Partners Ag Proteinas de union modificadas que inhiben la interaccion de receptor del factor de crecimiento endotelial vascular de glicoproteina a vegf-a
AU2013267310A1 (en) * 2012-06-01 2014-12-11 Ophthotech Corporation Compositions comprising an anti-PDGF aptamer and a VEGF antagonist
US20130323242A1 (en) 2012-06-01 2013-12-05 Ophthotech Corp. Compositions comprising an anti-pdgf aptamer and a vegf antagonist
EP2890389A1 (en) * 2012-08-28 2015-07-08 Novartis AG Use of a vegf antagonist in treating ocular vascular proliferative diseases
US20160137717A1 (en) * 2013-06-20 2016-05-19 Gabriela Burian Use of a vegf antagonist in treating choroidal neovascularisation
EP3071181B1 (en) 2013-11-18 2021-03-24 Formycon AG Pharmaceutical composition of an anti-vegf antibody
CN106456757A (zh) 2014-05-12 2017-02-22 福尔密孔股份公司 含有vegf拮抗剂的预填充塑料注射器
KR101808234B1 (ko) * 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
CN108290004A (zh) 2015-11-18 2018-07-17 福尔密孔股份公司 含有vegf拮抗剂的预填充塑料注射器
US10576128B2 (en) 2016-01-26 2020-03-03 Formycon Ag Liquid formulation of a VEGF antagonist

Also Published As

Publication number Publication date
AU2017213103B2 (en) 2022-08-11
US12551529B2 (en) 2026-02-17
US20230248806A1 (en) 2023-08-10
JP2019504882A (ja) 2019-02-21
US20190030123A1 (en) 2019-01-31
US20200237862A1 (en) 2020-07-30
AU2017213103A1 (en) 2018-07-26
CA3011638C (en) 2023-01-10
EP3407868A1 (en) 2018-12-05
CA3011638A1 (en) 2017-08-03
WO2017129685A1 (en) 2017-08-03
US10576128B2 (en) 2020-03-03

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
EP3071181B1 (en) Pharmaceutical composition of an anti-vegf antibody
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
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
CN114340674A (zh) 抗-IL-23p19抗体制剂
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
CN116688115B (zh) 一种PD-L1/TGF-β双功能融合蛋白制剂及其用途
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
HK40109650A (zh) 制剂
HK40118051A (zh) Csf-1r抗体制剂
HK40107164A (zh) Csf-1r抗体制剂
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