CO2020004838A2 - Dosis y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxística nocturna (hpn) y el síndrome hemolítico urémico atípico (shua) - Google Patents

Dosis y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxística nocturna (hpn) y el síndrome hemolítico urémico atípico (shua)

Info

Publication number
CO2020004838A2
CO2020004838A2 CONC2020/0004838A CO2020004838A CO2020004838A2 CO 2020004838 A2 CO2020004838 A2 CO 2020004838A2 CO 2020004838 A CO2020004838 A CO 2020004838A CO 2020004838 A2 CO2020004838 A2 CO 2020004838A2
Authority
CO
Colombia
Prior art keywords
shua
hpn
antibodies
dosage
administration
Prior art date
Application number
CONC2020/0004838A
Other languages
English (en)
Spanish (es)
Inventor
Lori Shafner
Scott T Rottinghaus
Rajendra Pradhan
Andrew Damokosh
Xiang Gao
Original Assignee
Alexion Pharma 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 Alexion Pharma Inc filed Critical Alexion Pharma Inc
Publication of CO2020004838A2 publication Critical patent/CO2020004838A2/es

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Classifications

    • 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
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • C07K16/2803—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 immunoglobulin superfamily
    • C07K16/283—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 immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • 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
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/526—CH3 domain
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
CONC2020/0004838A 2017-10-26 2020-04-20 Dosis y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxística nocturna (hpn) y el síndrome hemolítico urémico atípico (shua) CO2020004838A2 (es)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201762577244P 2017-10-26 2017-10-26
US201862643056P 2018-03-14 2018-03-14
US201862643608P 2018-03-15 2018-03-15
US201862662503P 2018-04-25 2018-04-25
US201862685505P 2018-06-15 2018-06-15
US201862685425P 2018-06-15 2018-06-15
PCT/US2018/057760 WO2019084438A1 (en) 2017-10-26 2018-10-26 ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)

Publications (1)

Publication Number Publication Date
CO2020004838A2 true CO2020004838A2 (es) 2020-05-29

Family

ID=64661436

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2020/0004838A CO2020004838A2 (es) 2017-10-26 2020-04-20 Dosis y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxística nocturna (hpn) y el síndrome hemolítico urémico atípico (shua)

Country Status (11)

Country Link
US (3) US12128101B2 (enExample)
EP (1) EP3700928A1 (enExample)
JP (4) JP7518764B2 (enExample)
KR (2) KR20200070355A (enExample)
CN (2) CN118512588A (enExample)
AU (1) AU2018354404B2 (enExample)
BR (1) BR112020008182A2 (enExample)
CA (1) CA3080187A1 (enExample)
CO (1) CO2020004838A2 (enExample)
MX (2) MX2020004284A (enExample)
WO (1) WO2019084438A1 (enExample)

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CN109475630A (zh) 2016-05-27 2019-03-15 瑞颂医药公司 治疗难治性全身型重症肌无力的方法
PT3658184T (pt) 2017-07-27 2023-11-29 Alexion Pharma Inc Formulações de anticorpo anti-c5 de elevada concentração
BR112020008182A2 (pt) 2017-10-26 2020-10-27 Alexion Pharmaceuticals, Inc. dosagem e administração de anticorpos anti-c5 para tratamento de hemoglobinúria paroxística noturna (hpn) e síndrome hemolítica urêmica atípica (shua)
JP7520725B2 (ja) * 2018-05-31 2024-07-23 アレクシオン ファーマシューティカルズ， インコーポレイテッド 小児患者における発作性夜間ヘモグロビン尿症（ｐｎｈ）の治療のための抗ｃ５抗体の用量および投与
US12460012B2 (en) * 2018-06-04 2025-11-04 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-C5 antibodies for treatment of atypical hemolytic uremic syndrome (aHUS) in pediatric patients
EP3814373A1 (en) 2018-06-28 2021-05-05 Alexion Pharmaceuticals, Inc. Methods of producing anti-c5 antibodies
US20210301004A1 (en) * 2018-08-01 2021-09-30 Chugai Seiyaku Kabushiki Kaisha A pharmaceutical composition for use in the treatment or prevention of a c5-related disease and a method for treating or preventing a c5-related disease
US12240893B2 (en) * 2018-10-30 2025-03-04 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH)
JP7511566B2 (ja) * 2019-01-25 2024-07-05 アレクシオン ファーマシューティカルズ， インコーポレイテッド 非典型溶血性尿毒症症候群（ａＨＵＳ）の処置のための抗Ｃ５抗体の投薬量及び投与
CN113614106A (zh) * 2019-02-14 2021-11-05 亚力兄制药公司 抗c5抗体用于治疗全身型重症肌无力的剂量和施用
WO2020242849A1 (en) * 2019-05-24 2020-12-03 Alexion Pharmaceuticals, Inc. Methods of treating vitiligo using an anti-c5 antibody
EP4003408A1 (en) * 2019-07-31 2022-06-01 F. Hoffmann-La Roche AG Dosage and administration regimen for the treatment or prevention of c5-related diseases by the use of the anti-c5 antibody crovalimab
KR20240033090A (ko) * 2019-07-31 2024-03-12 에프. 호프만-라 로슈 아게 항-c5 항체 크로발리맙의 사용에 의한 c5-관련 질병의 치료 또는 예방을 위한 투여량 및 투여 섭생
BR112022002831A2 (pt) * 2019-08-16 2022-06-28 Regeneron Pharma Formulações anti-c5 de alta concentração
WO2021091937A1 (en) * 2019-11-08 2021-05-14 Alexion Pharmaceuticals, Inc. High concentration anti-c5 antibody formulations
EP4081805A1 (en) * 2019-12-23 2022-11-02 Alexion Pharmaceuticals, Inc. Methods of treating pregnancy-associated atypical hemolytic uremic syndrome using an anti-c5 antibody
US20210280304A1 (en) * 2020-03-08 2021-09-09 Gen LI Integrated clinical trial design and design optimization
MX2023001702A (es) * 2020-08-13 2023-03-09 Alexion Pharma Inc Dosificacion y administracion de anticuerpos anti-c5 para el tratamiento de la microangiopatia trombotica asociada al trasplante de celulas madre hematopoyeticas (hsct-tma).
CA3196434A1 (en) * 2020-10-23 2022-04-28 Krista K. JOHNSON Methods of treating patients having complement disorders using anti-c5 antibodies
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