CR20190538A - Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas - Google Patents

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

Info

Publication number
CR20190538A
CR20190538A CR20190538A CR20190538A CR20190538A CR 20190538 A CR20190538 A CR 20190538A CR 20190538 A CR20190538 A CR 20190538A CR 20190538 A CR20190538 A CR 20190538A CR 20190538 A CR20190538 A CR 20190538A
Authority
CR
Costa Rica
Prior art keywords
methods
human antibody
antibody formulations
formulations
rankl
Prior art date
Application number
CR20190538A
Other languages
English (en)
Inventor
Pavan K Ghattyvenkatakrishna
Lyanne M Wong
Monica Michelle Goss
Stephen Robert Brych
Jaymille Fallon
Jian Hua Gu
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=62165668&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CR20190538(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of CR20190538A publication Critical patent/CR20190538A/es

Links

Classifications

    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IG], 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Epidemiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Pulmonology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

En la presente se describen formulaciones farmacéuticas acuosas que comprenden denosumab u otro anticuerpo monoclonal anti-RANKL humano o parte de este, y características de pH, sistemas tampón e inhibidores de agregación de aminoácidos. También se describe una presentación de la formulación para su uso, por ejemplo, en un vial de único uso, una jeringa de único uso, o un recipiente de vidrio, métodos de uso de las formulaciones y artículos para prevenir o tratar enfermedades, y kits relacionados.
CR20190538A 2017-04-28 2018-04-27 Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas CR20190538A (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
CR20190538A true CR20190538A (es) 2020-02-26

Family

ID=62165668

Family Applications (2)

Application Number Title Priority Date Filing Date
CR20190538A CR20190538A (es) 2017-04-28 2018-04-27 Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas
CR20250034A CR20250034A (es) 2017-04-28 2018-04-27 FORMULACIONES DE ANTICUERPOS HUMANOS ANTI-RANKL Y MÉTODOS DE USO DE ESTAS(Divisional de la solicitud 2019-0538)

Family Applications After (1)

Application Number Title Priority Date Filing Date
CR20250034A CR20250034A (es) 2017-04-28 2018-04-27 FORMULACIONES DE ANTICUERPOS HUMANOS ANTI-RANKL Y MÉTODOS DE USO DE ESTAS(Divisional de la solicitud 2019-0538)

Country Status (37)

Country Link
US (3) US11192952B2 (es)
EP (3) EP3615066B1 (es)
JP (4) JP7190822B2 (es)
KR (2) KR20240110083A (es)
CN (2) CN110621342B (es)
AR (1) AR111497A1 (es)
AU (2) AU2018260750B2 (es)
BR (1) BR112019022188A2 (es)
CA (1) CA3054165A1 (es)
CL (3) CL2019003032A1 (es)
CO (1) CO2019011463A2 (es)
CR (2) CR20190538A (es)
DK (2) DK3615066T5 (es)
EA (1) EA201992570A1 (es)
ES (2) ES2997833T3 (es)
FI (2) FI3615066T3 (es)
HR (2) HRP20240167T1 (es)
HU (2) HUE069382T2 (es)
IL (2) IL293127B2 (es)
JO (2) JOP20190255B1 (es)
LT (2) LT3615066T (es)
MA (2) MA62173B1 (es)
MX (1) MX2023013460A (es)
MY (1) MY202479A (es)
PE (2) PE20251534A1 (es)
PH (1) PH12019502444A1 (es)
PL (2) PL3615066T3 (es)
PT (2) PT4190355T (es)
RS (2) RS65299B1 (es)
SG (1) SG11201909998TA (es)
SI (2) SI3615066T1 (es)
SM (2) SMT202400491T1 (es)
TN (2) TN2019000297A1 (es)
TW (2) TWI903512B (es)
UY (2) UY37707A (es)
WO (1) WO2018200918A1 (es)
ZA (1) ZA202205141B (es)

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Publication number Publication date
MA48462B1 (fr) 2024-05-31
TWI839331B (zh) 2024-04-21
RS65299B1 (sr) 2024-04-30
EA201992570A1 (ru) 2020-03-20
PE20200343A1 (es) 2020-02-14
AU2018260750A1 (en) 2019-08-29
JOP20190255B1 (ar) 2024-12-22
SI3615066T1 (sl) 2024-04-30
JP7356525B2 (ja) 2023-10-04
EP3615066B1 (en) 2023-12-27
SMT202400095T1 (it) 2024-05-14
US11192952B2 (en) 2021-12-07
CR20250034A (es) 2025-03-06
LT4190355T (lt) 2024-12-27
PT4190355T (pt) 2024-12-05
HUE065544T2 (hu) 2024-05-28
MX2023013460A (es) 2023-12-15
TN2019000297A1 (en) 2021-05-07
AR111497A1 (es) 2019-07-17
CL2023002505A1 (es) 2024-03-08
LT3615066T (lt) 2024-02-26
EP4477667A2 (en) 2024-12-18
EP4190355B1 (en) 2024-09-25
SI4190355T1 (sl) 2025-02-28
JP2022062059A (ja) 2022-04-19
US20200354463A1 (en) 2020-11-12
TW202435914A (zh) 2024-09-16
UY40974A (es) 2024-12-13
TN2021000055A1 (en) 2022-10-03
FI4190355T3 (fi) 2024-12-07
JP2023166396A (ja) 2023-11-21
US20220143181A1 (en) 2022-05-12
AU2025205470A1 (en) 2025-08-14
SG11201909998TA (en) 2019-11-28
WO2018200918A8 (en) 2019-10-17
JP2018188430A (ja) 2018-11-29
PE20251534A1 (es) 2025-06-05
CL2019003032A1 (es) 2020-02-21
PH12019502444A1 (en) 2020-07-20
JOP20190255A1 (ar) 2019-10-27
MA62173B1 (fr) 2025-01-31
ES2997833T3 (en) 2025-02-18
IL268704B (en) 2022-06-01
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