MA48462B1 - Formulations d'anticorps anti-rankl humains, et leurs méthodes d'utilisation - Google Patents

Formulations d'anticorps anti-rankl humains, et leurs méthodes d'utilisation

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Publication number
MA48462B1
MA48462B1 MA48462A MA48462A MA48462B1 MA 48462 B1 MA48462 B1 MA 48462B1 MA 48462 A MA48462 A MA 48462A MA 48462 A MA48462 A MA 48462A MA 48462 B1 MA48462 B1 MA 48462B1
Authority
MA
Morocco
Prior art keywords
formulations
methods
human anti
rankl antibodies
relates
Prior art date
Application number
MA48462A
Other languages
English (en)
Other versions
MA48462A (fr
Inventor
Stephen Brych
Lyanne Wong
Jaymille Fallon
Monica Goss
Jian Gu
Pavan Ghattyvenkatakrishna
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=MA48462(B1) "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 MA48462A publication Critical patent/MA48462A/fr
Publication of MA48462B1 publication Critical patent/MA48462B1/fr

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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

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  • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (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)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Pulmonology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des formulations pharmaceutiques aqueuses comprenant du dénosumab ou un autre anticorps monoclonal anti-rankl humain ou une partie de celui-ci, et des caractéristiques de ph, des systèmes tampons et des inhibiteurs d'agrégation d'acides aminés. L'invention concerne également une présentation de la formulation destinée à être utilisée, par exemple dans un flacon à usage unique, une seringue à usage unique ou un récipient en verre, des méthodes d'utilisation des formulations et des articles destinés à prévenir ou à traiter des maladies, et des kits associés.
MA48462A 2017-04-28 2018-04-27 Formulations d'anticorps anti-rankl humains, et leurs méthodes d'utilisation MA48462B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762492056P 2017-04-28 2017-04-28
PCT/US2018/029728 WO2018200918A1 (fr) 2017-04-28 2018-04-27 Formulations d'anticorps anti-rankl humains, et leurs méthodes d'utilisation

Publications (2)

Publication Number Publication Date
MA48462A MA48462A (fr) 2020-03-04
MA48462B1 true MA48462B1 (fr) 2024-05-31

Family

ID=62165668

Family Applications (2)

Application Number Title Priority Date Filing Date
MA62173A MA62173B1 (fr) 2017-04-28 2018-04-27 Formulations d'anticorps anti-rankl humains et leurs procédés d'utilisation
MA48462A MA48462B1 (fr) 2017-04-28 2018-04-27 Formulations d'anticorps anti-rankl humains, et leurs méthodes d'utilisation

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MA62173A MA62173B1 (fr) 2017-04-28 2018-04-27 Formulations d'anticorps anti-rankl humains et leurs procédés d'utilisation

Country Status (37)

Country Link
US (3) US11192952B2 (fr)
EP (3) EP4190355B1 (fr)
JP (4) JP7190822B2 (fr)
KR (2) KR20240110083A (fr)
CN (2) CN110621342B (fr)
AR (1) AR111497A1 (fr)
AU (2) AU2018260750B2 (fr)
BR (1) BR112019022188A2 (fr)
CA (1) CA3054165A1 (fr)
CL (3) CL2019003032A1 (fr)
CO (1) CO2019011463A2 (fr)
CR (2) CR20190538A (fr)
DK (2) DK3615066T5 (fr)
EA (1) EA201992570A1 (fr)
ES (2) ES2973572T3 (fr)
FI (2) FI4190355T3 (fr)
HR (2) HRP20240167T1 (fr)
HU (2) HUE069382T2 (fr)
IL (2) IL293127B2 (fr)
JO (2) JOP20190255B1 (fr)
LT (2) LT3615066T (fr)
MA (2) MA62173B1 (fr)
MX (1) MX2023013460A (fr)
MY (1) MY202479A (fr)
PE (2) PE20200343A1 (fr)
PH (1) PH12019502444A1 (fr)
PL (2) PL4190355T3 (fr)
PT (2) PT4190355T (fr)
RS (2) RS65299B1 (fr)
SG (1) SG11201909998TA (fr)
SI (2) SI3615066T1 (fr)
SM (2) SMT202400095T1 (fr)
TN (2) TN2019000297A1 (fr)
TW (2) TWI903512B (fr)
UY (2) UY37707A (fr)
WO (1) WO2018200918A1 (fr)
ZA (1) ZA202205141B (fr)

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HRP20240167T1 (hr) 2017-04-28 2024-04-26 Amgen Inc. Formulacije ljudskih anti-rankl protutijela i postupci njihove upotrebe
WO2018200533A1 (fr) * 2017-04-28 2018-11-01 Amgen Inc. Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
KR20210079373A (ko) * 2018-11-16 2021-06-29 삼성바이오에피스 주식회사 단백질을 포함하는 안정한 액상 조성물
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
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
TWI759867B (zh) * 2019-09-19 2022-04-01 大陸商信達生物製藥（蘇州）有限公司 抗前蛋白轉化酶枯草桿菌蛋白酶／ｋｅｘｉｎ型９抗體用於製備治療膽固醇相關疾病之藥物的用途
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
AU2021377176A1 (en) * 2020-11-11 2023-06-22 Hq Han Bifunctional antagonists of activin/tgf-beta and rankl and uses thereof
CA3218542A1 (fr) * 2021-05-12 2022-11-17 Hua Ying Molecule de liaison a l'antigene se liant specifiquement a rankl et ngf, et son utilisation medicale
AU2022274319A1 (en) * 2021-05-12 2024-01-04 Anaptysbio, Inc. Antibody composition
IL310275A (en) 2021-08-12 2024-03-01 Amgen Inc Antibody formulations
US20250297020A1 (en) * 2021-11-23 2025-09-25 Adalta Limited Rank-l binding molecules
CN118139882A (zh) * 2022-03-24 2024-06-04 安济盛生物医药有限公司 骨骼肌肉系统疾病的治疗
JP2025532122A (ja) 2022-09-23 2025-09-29 ザ ユニヴァーシティー オブ ノース カロライナ アト チャペル ヒル 黒色腫の治療のための方法及び組成物
WO2024104409A1 (fr) * 2022-11-16 2024-05-23 苏州盛迪亚生物医药有限公司 Composition pharmaceutique comprenant des anticorps bispécifiques anti-rankl-ngf
WO2024184280A1 (fr) * 2023-03-03 2024-09-12 Alvotech Hf Formulation de dénosumab
CN121752600A (zh) * 2023-08-17 2026-03-27 中国抗体制药有限公司 靶向rankl和硬骨素的抗体及其用途
WO2025116648A1 (fr) * 2023-12-01 2025-06-05 삼성바이오에피스 주식회사 FORMULATION LIQUIDE STABLE SANS TAMPON D'ANTICORPS ANTI-IL-4Rα

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Also Published As

Publication number Publication date
MA48462A (fr) 2020-03-04
TN2021000055A1 (en) 2022-10-03
FI4190355T3 (fi) 2024-12-07
TWI903512B (zh) 2025-11-01
PH12019502444A1 (en) 2020-07-20
IL293127B2 (en) 2024-06-01
UY37707A (es) 2018-10-31
SMT202400095T1 (it) 2024-05-14
US11192952B2 (en) 2021-12-07
CL2019003032A1 (es) 2020-02-21
EP4477667A3 (fr) 2025-05-07
DK3615066T3 (da) 2024-03-11
KR20190140464A (ko) 2019-12-19
TW201841654A (zh) 2018-12-01
EP4477667A2 (fr) 2024-12-18
PE20251534A1 (es) 2025-06-05
JOP20240115B1 (ar) 2025-10-01
AU2018260750A1 (en) 2019-08-29
CL2020002012A1 (es) 2020-10-16
LT3615066T (lt) 2024-02-26
US20220143181A1 (en) 2022-05-12
KR20240110083A (ko) 2024-07-12
TN2019000297A1 (en) 2021-05-07
SG11201909998TA (en) 2019-11-28
EP3615066B1 (fr) 2023-12-27
TW202435914A (zh) 2024-09-16
MX2023013460A (es) 2023-12-15
CR20250034A (es) 2025-03-06
EP4190355A1 (fr) 2023-06-07
HUE065544T2 (hu) 2024-05-28
IL268704A (en) 2019-10-31
AR111497A1 (es) 2019-07-17
CN118987200A (zh) 2024-11-22
MY202479A (en) 2024-04-30
AU2018260750B2 (en) 2025-04-17
PL3615066T3 (pl) 2024-04-29
EP4190355B1 (fr) 2024-09-25
MA62173B1 (fr) 2025-01-31
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CA3054165A1 (fr) 2018-11-01
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