BR112021014472A2 - Dosagem e administração de anticorpos anti-c5 para tratamento da síndrome urêmica hemolítica atípica (ahus) - Google Patents

Dosagem e administração de anticorpos anti-c5 para tratamento da síndrome urêmica hemolítica atípica (ahus) Download PDF

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Publication number
BR112021014472A2
BR112021014472A2 BR112021014472-2A BR112021014472A BR112021014472A2 BR 112021014472 A2 BR112021014472 A2 BR 112021014472A2 BR 112021014472 A BR112021014472 A BR 112021014472A BR 112021014472 A2 BR112021014472 A2 BR 112021014472A2
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Brazil
Prior art keywords
antibody
days
day
patient
treatment
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BR112021014472-2A
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English (en)
Portuguese (pt)
Inventor
Lori PAYTON
Christian MIx
Rajendra Pradhan
Andrew Damokosh
Eugene Scott SWENSON
Xiang Gao
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Alexion Pharmaceuticals, Inc.
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Application filed by Alexion Pharmaceuticals, Inc. filed Critical Alexion Pharmaceuticals, Inc.
Publication of BR112021014472A2 publication Critical patent/BR112021014472A2/pt

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    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • 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
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • 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
    • C07K16/2803—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 immunoglobulin superfamily
    • C07K16/283—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 immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
BR112021014472-2A 2019-01-25 2020-01-24 Dosagem e administração de anticorpos anti-c5 para tratamento da síndrome urêmica hemolítica atípica (ahus) BR112021014472A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962796953P 2019-01-25 2019-01-25
US62/796,953 2019-01-25
PCT/US2020/014998 WO2020154626A1 (en) 2019-01-25 2020-01-24 Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus)

Publications (1)

Publication Number Publication Date
BR112021014472A2 true BR112021014472A2 (pt) 2021-09-21

Family

ID=69740563

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021014472-2A BR112021014472A2 (pt) 2019-01-25 2020-01-24 Dosagem e administração de anticorpos anti-c5 para tratamento da síndrome urêmica hemolítica atípica (ahus)

Country Status (18)

Country Link
US (1) US20220235121A1 (https=)
EP (1) EP3914617B1 (https=)
JP (2) JP7511566B2 (https=)
KR (2) KR20210119420A (https=)
CN (2) CN117838856A (https=)
AU (3) AU2020213121A1 (https=)
BR (1) BR112021014472A2 (https=)
CA (1) CA3127797A1 (https=)
DK (1) DK3914617T3 (https=)
ES (1) ES2980453T3 (https=)
FI (1) FI3914617T3 (https=)
HU (1) HUE067202T2 (https=)
LT (1) LT3914617T (https=)
MX (1) MX2021008919A (https=)
PL (1) PL3914617T3 (https=)
PT (1) PT3914617T (https=)
SI (1) SI3914617T1 (https=)
WO (1) WO2020154626A1 (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019517473A (ja) 2016-05-27 2019-06-24 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Ａｌｅｘｉｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 難治性全身型重症筋無力症の処置のための方法
SI3658184T1 (sl) 2017-07-27 2024-01-31 Alexion Pharmaceuticals, Inc., Formulacije z visoko koncentracijo protiteles proti-C5
CA3080187A1 (en) 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)
US12404320B2 (en) 2018-05-31 2025-09-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients
JP7577542B2 (ja) 2018-06-04 2024-11-05 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 小児患者における非典型溶血性尿毒症症候群（ａＨＵＳ）の治療のための抗Ｃ５抗体の用量および投与
WO2020006266A1 (en) 2018-06-28 2020-01-02 Alexion Pharmaceuticals, Inc. Methods of producing anti-c5 antibodies
CN112996561A (zh) 2018-10-30 2021-06-18 亚力兄制药公司 用于治疗阵发性睡眠性血红蛋白尿症(pnh)的抗c5抗体的皮下剂量和施用
KR20230134533A (ko) * 2021-01-22 2023-09-21 알렉시온 파마슈티칼스, 인코포레이티드 항-c5 항체를 이용한 보체 매개 혈전성 미세혈관병증의치료 방법
EP4333845A1 (en) * 2021-05-07 2024-03-13 Novartis AG Iptacopan for the treatment of atypical hemolytic uremic syndrome

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6074642A (en) 1994-05-02 2000-06-13 Alexion Pharmaceuticals, Inc. Use of antibodies specific to human complement component C5 for the treatment of glomerulonephritis
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
WO2014099546A1 (en) 2012-12-19 2014-06-26 Promerus, Llc Process for the preparation of high purity norbornene alkanols and derivatives thereof
NZ631007A (en) 2014-03-07 2015-10-30 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
CN107207607B (zh) 2014-12-19 2021-05-04 中外制药株式会社 抗-c5抗体及使用方法
EP3402816A1 (en) * 2016-01-11 2018-11-21 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
ES2984352T3 (es) 2016-06-14 2024-10-29 Regeneron Pharma Anticuerpos anti-C5 y usos de los mismos
SI3658184T1 (sl) * 2017-07-27 2024-01-31 Alexion Pharmaceuticals, Inc., Formulacije z visoko koncentracijo protiteles proti-C5
CA3080187A1 (en) * 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)
JP7577542B2 (ja) * 2018-06-04 2024-11-05 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 小児患者における非典型溶血性尿毒症症候群（ａＨＵＳ）の治療のための抗Ｃ５抗体の用量および投与

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DK3914617T3 (da) 2024-05-27
AU2026200805A1 (en) 2026-02-26
JP2024120942A (ja) 2024-09-05
HUE067202T2 (hu) 2024-10-28
PL3914617T3 (pl) 2024-08-05
CN117838856A (zh) 2024-04-09
MX2021008919A (es) 2021-11-04
CN113614105A (zh) 2021-11-05
CA3127797A1 (en) 2020-07-30
KR20250016490A (ko) 2025-02-03
AU2020213121A1 (en) 2021-08-12
ES2980453T3 (es) 2024-10-01
JP7823117B2 (ja) 2026-03-03
KR20210119420A (ko) 2021-10-05
PT3914617T (pt) 2024-05-31
US20220235121A1 (en) 2022-07-28
JP2022518507A (ja) 2022-03-15
AU2024266818A1 (en) 2025-01-02
FI3914617T3 (fi) 2024-05-24
SI3914617T1 (sl) 2024-06-28
LT3914617T (lt) 2024-05-27
WO2020154626A1 (en) 2020-07-30
EP3914617B1 (en) 2024-03-13
EP3914617A1 (en) 2021-12-01
AU2024266818B2 (en) 2026-02-19
JP7511566B2 (ja) 2024-07-05

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