PE20200343A1 - Formulaciones de anticuerpos humanos anti-rankl y metodos de uso de estas - Google Patents

Formulaciones de anticuerpos humanos anti-rankl y metodos de uso de estas

Info

Publication number
PE20200343A1
PE20200343A1 PE2019002120A PE2019002120A PE20200343A1 PE 20200343 A1 PE20200343 A1 PE 20200343A1 PE 2019002120 A PE2019002120 A PE 2019002120A PE 2019002120 A PE2019002120 A PE 2019002120A PE 20200343 A1 PE20200343 A1 PE 20200343A1
Authority
PE
Peru
Prior art keywords
methods
human antibody
antibody formulations
formulations
rankl
Prior art date
Application number
PE2019002120A
Other languages
English (en)
Inventor
Lyanne M Wong
Jaymille Fallon
Monica Michelle Goss
Jian Hua Gu
Pavan K Ghattyvenkatakrishna
Stephen Robert Brych
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Publication of PE20200343A1 publication Critical patent/PE20200343A1/es

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Classifications

    • 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
    • A61K47/26—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
    • A61K9/08—Solutions
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Pulmonology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

En la presente se describen formulaciones farmaceuticas acuosas que comprenden denosumab u otro anticuerpo monoclonal anti-RANKL humano o parte de este, y caracteristicas de pH, sistemas tampon e inhibidores de agregacion de aminoacidos. Tambien se describe una presentacion de la formulacion para su uso, por ejemplo, en un vial de unico uso, una jeringa de unico uso, o un recipiente de vidrio, metodos de uso de las formulaciones y articulos para prevenir o tratar enfermedades, y kits relacionados.
PE2019002120A 2017-04-28 2018-04-27 Formulaciones de anticuerpos humanos anti-rankl y metodos de uso de estas PE20200343A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762492056P 2017-04-28 2017-04-28
PCT/US2018/029728 WO2018200918A1 (en) 2017-04-28 2018-04-27 Formulations of human anti-rankl antibodies, and methods of using the same

Publications (1)

Publication Number Publication Date
PE20200343A1 true PE20200343A1 (es) 2020-02-14

Family

ID=62165668

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2019002120A PE20200343A1 (es) 2017-04-28 2018-04-27 Formulaciones de anticuerpos humanos anti-rankl y metodos de uso de estas

Country Status (35)

Country Link
US (2) US11192952B2 (es)
EP (2) EP4190355B1 (es)
JP (3) JP7190822B2 (es)
KR (2) KR102681171B1 (es)
CN (1) CN110621342B (es)
AR (1) AR111497A1 (es)
AU (1) AU2018260750A1 (es)
BR (1) BR112019022188A2 (es)
CA (1) CA3054165A1 (es)
CL (3) CL2019003032A1 (es)
CO (1) CO2019011463A2 (es)
CR (1) CR20190538A (es)
DK (1) DK3615066T5 (es)
EA (1) EA201992570A1 (es)
ES (1) ES2973572T3 (es)
FI (1) FI3615066T3 (es)
HR (1) HRP20240167T1 (es)
HU (1) HUE065544T2 (es)
IL (2) IL293127B2 (es)
JO (1) JOP20190255A1 (es)
LT (1) LT3615066T (es)
MA (1) MA48462B1 (es)
MX (1) MX2023013460A (es)
MY (1) MY202479A (es)
PE (1) PE20200343A1 (es)
PH (1) PH12019502444A1 (es)
PL (1) PL3615066T3 (es)
PT (1) PT3615066T (es)
RS (1) RS65299B1 (es)
SG (1) SG11201909998TA (es)
SI (1) SI3615066T1 (es)
TN (2) TN2019000297A1 (es)
TW (1) TWI839331B (es)
UY (1) UY37707A (es)
WO (1) WO2018200918A1 (es)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113365658A (zh) * 2018-11-16 2021-09-07 三星Bioepis股份有限公司 包含蛋白质的稳定的液体组合物
CN109374779A (zh) * 2018-12-17 2019-02-22 杭州奕安济世生物药业有限公司 一种蔗糖含量的快速检测方法
BR112021015034A2 (pt) 2019-02-18 2021-10-05 Eli Lilly And Company Formulação de anticorpo terapêutico
CN111704670B (zh) * 2020-08-18 2020-11-03 迈威(上海)生物科技股份有限公司 重组抗RANKL抗体IgG2型的二硫键异构体及其纯化方法
KR20240006586A (ko) * 2021-05-12 2024-01-15 지앙수 헨그루이 파마슈티컬스 컴퍼니 리미티드 Rankl 및 ngf에 특이적으로 결합하는 항원 결합 분자, 및 이의 의학적 용도
IL310275A (en) 2021-08-12 2024-03-01 Amgen Inc Antibody formulations
WO2023092177A1 (en) * 2021-11-23 2023-06-01 Adalta Limited Rank-l binding molecules
WO2023179791A1 (en) * 2022-03-24 2023-09-28 Angitia Biomedicines Limited Treatment of musculoskeletal disorders
WO2024064878A1 (en) 2022-09-23 2024-03-28 The University Of North Carolina At Chapel Hill Methods and compositions for the treatment of melanoma
WO2024104409A1 (zh) * 2022-11-16 2024-05-23 苏州盛迪亚生物医药有限公司 一种含抗rankl-ngf双特异性抗体的药物组合物
WO2024184280A1 (en) * 2023-03-03 2024-09-12 Alvotech Hf Denosumab formulation

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YU103003A (sh) 2001-06-26 2006-05-25 Abgenix Inc. Antitela za opgl
PE20070684A1 (es) 2005-11-14 2007-08-06 Amgen Inc MOLECULAS QUIMERICAS DE ANTICUERPO RANKL-PTH/PTHrP
CA2672902C (en) 2006-12-21 2012-11-27 Amgen Inc. Formulations
US7951368B2 (en) * 2007-06-25 2011-05-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
AU2009210741A1 (en) * 2008-02-07 2009-08-13 Amgen Inc. Stabilized protein compositions
CL2009001735A1 (es) 2008-08-19 2010-02-19 Regeneron Pharma Anticuerpo humano o fragmento de union a antigeno del mismo que une e inhibe actividad de ligando del activador del receptor de nf-kb (rankl); adn codificante; vector de expresion; metodo para producir dicho anticuerpo; composicion farmaceutica que lo comprende; uso para atenuar o inhibir enfermedad o condicion mediada por rankl
US9265834B2 (en) * 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
WO2011141926A2 (en) 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
EP2433644A1 (en) 2010-09-22 2012-03-28 IMBA-Institut für Molekulare Biotechnologie GmbH Breast cancer therapeutics
CA2832560A1 (en) * 2011-04-07 2012-10-18 Glaxosmithkline Llc Formulations with reduced viscosity
KR101759694B1 (ko) 2011-10-28 2017-07-19 인테그리티 바이오, 아이엔씨. 아미노산을 함유하는 단백질 제제
TWI679019B (zh) 2013-04-29 2019-12-11 法商賽諾菲公司 抗ｉｌ－４／抗ｉｌ－１３之雙特異性抗體調配物
CN103965357B (zh) 2013-12-31 2016-08-17 嘉和生物药业有限公司 一种抗人rankl抗体
WO2015134406A1 (en) * 2014-03-03 2015-09-11 La Jolla Biologics, Inc. Stable aqueous recombinant protein formulations
CN106659785B (zh) 2014-05-07 2021-04-30 武田有限公司 包含gm-csf中和化合物的液体制剂

Also Published As

Publication number Publication date
CO2019011463A2 (es) 2019-10-31
HRP20240167T1 (hr) 2024-04-26
IL268704B (en) 2022-06-01
CL2023002505A1 (es) 2024-03-08
AU2018260750A1 (en) 2019-08-29
TWI839331B (zh) 2024-04-21
IL293127B1 (en) 2024-02-01
EP4190355A1 (en) 2023-06-07
JOP20190255A1 (ar) 2019-10-27
RS65299B1 (sr) 2024-04-30
KR20190140464A (ko) 2019-12-19
PT3615066T (pt) 2024-03-08
AR111497A1 (es) 2019-07-17
LT3615066T (lt) 2024-02-26
SI3615066T1 (sl) 2024-04-30
EA201992570A1 (ru) 2020-03-20
CL2019003032A1 (es) 2020-02-21
TN2021000055A1 (en) 2022-10-03
FI3615066T3 (fi) 2024-02-29
ES2973572T3 (es) 2024-06-20
CN110621342B (zh) 2024-08-02
JP2018188430A (ja) 2018-11-29
CL2020002012A1 (es) 2020-10-16
US11192952B2 (en) 2021-12-07
TW201841654A (zh) 2018-12-01
JP7190822B2 (ja) 2022-12-16
JP2023166396A (ja) 2023-11-21
JP7356525B2 (ja) 2023-10-04
DK3615066T3 (da) 2024-03-11
WO2018200918A1 (en) 2018-11-01
MA48462B1 (fr) 2024-05-31
UY37707A (es) 2018-10-31
EP4190355B1 (en) 2024-09-25
CR20190538A (es) 2020-02-26
PH12019502444A1 (en) 2020-07-20
IL268704A (en) 2019-10-31
US20220143181A1 (en) 2022-05-12
US20200354463A1 (en) 2020-11-12
HUE065544T2 (hu) 2024-05-28
MY202479A (en) 2024-04-30
MX2023013460A (es) 2023-12-15
EP3615066B1 (en) 2023-12-27
KR20240110083A (ko) 2024-07-12
PL3615066T3 (pl) 2024-04-29
KR102681171B1 (ko) 2024-07-05
EP3615066A1 (en) 2020-03-04
MA48462A (fr) 2020-03-04
WO2018200918A8 (en) 2019-10-17
CA3054165A1 (en) 2018-11-01
US11873343B2 (en) 2024-01-16
CN110621342A (zh) 2019-12-27
TN2019000297A1 (en) 2021-05-07
BR112019022188A2 (pt) 2020-05-12
IL293127B2 (en) 2024-06-01
IL293127A (en) 2022-07-01
DK3615066T5 (da) 2024-09-02
JP2022062059A (ja) 2022-04-19
SG11201909998TA (en) 2019-11-28

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