BR112022002831A2 - Formulações anti-c5 de alta concentração - Google Patents

Formulações anti-c5 de alta concentração

Info

Publication number
BR112022002831A2
BR112022002831A2 BR112022002831A BR112022002831A BR112022002831A2 BR 112022002831 A2 BR112022002831 A2 BR 112022002831A2 BR 112022002831 A BR112022002831 A BR 112022002831A BR 112022002831 A BR112022002831 A BR 112022002831A BR 112022002831 A2 BR112022002831 A2 BR 112022002831A2
Authority
BR
Brazil
Prior art keywords
formulations
high concentration
concentration anti
concentration
cemdisiran
Prior art date
Application number
BR112022002831A
Other languages
English (en)
Portuguese (pt)
Inventor
KLEPPE Mary
Patel Mayank
Tang Xiaolin
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of BR112022002831A2 publication Critical patent/BR112022002831A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/08Solutions
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
BR112022002831A 2019-08-16 2020-08-14 Formulações anti-c5 de alta concentração BR112022002831A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962888086P 2019-08-16 2019-08-16
PCT/US2020/046314 WO2021034639A1 (en) 2019-08-16 2020-08-14 High concentration anti-c5 formulations

Publications (1)

Publication Number Publication Date
BR112022002831A2 true BR112022002831A2 (pt) 2022-06-28

Family

ID=72560889

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022002831A BR112022002831A2 (pt) 2019-08-16 2020-08-14 Formulações anti-c5 de alta concentração

Country Status (15)

Country Link
US (1) US20210046182A1 (https=)
EP (1) EP4013784A1 (https=)
JP (2) JP7813222B2 (https=)
KR (1) KR20220047826A (https=)
CN (1) CN116782876A (https=)
AU (1) AU2020334880A1 (https=)
BR (1) BR112022002831A2 (https=)
CA (1) CA3145621A1 (https=)
CL (1) CL2022000340A1 (https=)
CO (1) CO2022001097A2 (https=)
IL (1) IL290034A (https=)
JO (1) JOP20220030A1 (https=)
MX (1) MX2022001896A (https=)
PH (1) PH12022550167A1 (https=)
WO (1) WO2021034639A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL288931B2 (en) 2013-03-14 2025-05-01 Alnylam Pharmaceuticals Inc Compositions comprising a complementary portion of C5 IRNA and methods of using them
CN107635527B (zh) 2015-03-10 2021-04-23 里珍纳龙药品有限公司 无菌刺穿系统和方法
CN116769024A (zh) 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
IL308643B2 (en) 2017-05-05 2025-02-01 Regeneron Pharma Auto-injector
CA3274059A1 (en) 2017-12-13 2026-03-02 Regeneron Pharmaceuticals, Inc. Anti-c5 antibody combinations and uses thereof
US20240415980A1 (en) 2021-10-28 2024-12-19 Regeneron Pharmaceuticals, Inc. Crispr/cas-related methods and compositions for knocking out c5
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector
KR20250044336A (ko) * 2022-07-27 2025-03-31 세파론 엘엘씨 궤양성 결장염 및 크론병의 치료를 위한 항-tl1a 항체
IL318297A (en) * 2022-07-27 2025-03-01 Cephalon Llc Anti-TL1A antibody formulations
JP2025536552A (ja) * 2022-10-28 2025-11-07 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 抗C5抗体/C5 iRNA合剤および併用療法
CN121548440A (zh) 2023-06-16 2026-02-17 里珍纳龙药品有限公司 医疗装置包装及相关方法
CN116712390B (zh) * 2023-08-04 2023-11-14 上海览屹医药科技有限公司 一种高浓度高稳定性的抗体制剂及其制备方法
WO2025075970A1 (en) 2023-10-02 2025-04-10 Regeneron Pharmaceuticals, Inc. Drug delivery device safety system
CN118460651B (zh) * 2024-07-10 2025-03-18 凯莱英医药集团(天津)股份有限公司 制备Cemdisiran的方法
CN119454939A (zh) * 2024-11-28 2025-02-18 北海康成(苏州)生物制药有限公司 一种欧莫扑拜单抗原液及其制备方法

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5981501A (en) 1995-06-07 1999-11-09 Inex Pharmaceuticals Corp. Methods for encapsulating plasmids in lipid bilayers
AU733310C (en) 1997-05-14 2001-11-29 University Of British Columbia, The High efficiency encapsulation of charged therapeutic agents in lipid vesicles
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ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
CA2638811A1 (en) * 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
CA2674608A1 (en) * 2007-01-09 2008-07-17 Wyeth Anti-il-13 antibody formulations and uses thereof
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PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
AU2010221156A1 (en) * 2009-03-06 2011-09-22 Genentech, Inc. Antibody formulation
KR101766408B1 (ko) 2009-06-10 2017-08-10 알닐람 파마슈티칼스 인코포레이티드 향상된 지질 조성물
IL288931B2 (en) 2013-03-14 2025-05-01 Alnylam Pharmaceuticals Inc Compositions comprising a complementary portion of C5 IRNA and methods of using them
US10238700B2 (en) * 2014-01-02 2019-03-26 Genelux Corporation Oncolytic virus adjunct therapy with agents that increase virus infectivity
CA2940319A1 (en) 2014-03-20 2015-09-24 Inflarx Gmbh Inhibitors of c5a for the treatment of viral pneumonia
WO2017055966A1 (en) * 2015-10-01 2017-04-06 Pfizer Inc. Low viscosity antibody compositions
EP3464351A1 (en) 2016-06-07 2019-04-10 Novartis AG Anti-c5 antibody for treating patients with complement c5 polymorphism
CN116769024A (zh) * 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
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CA3274059A1 (en) * 2017-12-13 2026-03-02 Regeneron Pharmaceuticals, Inc. Anti-c5 antibody combinations and uses thereof

Also Published As

Publication number Publication date
CA3145621A1 (en) 2021-02-25
JP2022544589A (ja) 2022-10-19
US20210046182A1 (en) 2021-02-18
MX2022001896A (es) 2022-06-02
AU2020334880A1 (en) 2022-03-24
PH12022550167A1 (en) 2023-05-08
CO2022001097A2 (es) 2022-03-08
KR20220047826A (ko) 2022-04-19
CN116782876A (zh) 2023-09-19
JP2026003133A (ja) 2026-01-09
JOP20220030A1 (ar) 2023-01-30
IL290034A (en) 2022-03-01
CL2022000340A1 (es) 2022-10-07
WO2021034639A1 (en) 2021-02-25
JP7813222B2 (ja) 2026-02-12
WO2021034639A4 (en) 2021-04-15
EP4013784A1 (en) 2022-06-22

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Legal Events

Date Code Title Description
B154 Notification of filing of divisional application [chapter 15.50 patent gazette]

Free format text: O PEDIDO FOI DIVIDIDO NO BR122023016279-0 PROTOCOLO 870230071756 EM 14/08/2023 11:53.