CN117838856A - 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用 - Google Patents

用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用 Download PDF

Info

Publication number
CN117838856A
CN117838856A CN202410035211.2A CN202410035211A CN117838856A CN 117838856 A CN117838856 A CN 117838856A CN 202410035211 A CN202410035211 A CN 202410035211A CN 117838856 A CN117838856 A CN 117838856A
Authority
CN
China
Prior art keywords
antibody
treatment
patient
patients
days
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN202410035211.2A
Other languages
English (en)
Chinese (zh)
Inventor
L·佩顿
C·米克斯
R·普拉丹
A·达莫科什
E·S·斯文森
X·高
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alexion Pharmaceuticals Inc
Original Assignee
Alexion Pharmaceuticals 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 Pharmaceuticals Inc filed Critical Alexion Pharmaceuticals Inc
Publication of CN117838856A publication Critical patent/CN117838856A/zh
Pending legal-status Critical Current

Links

Classifications

    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • 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
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/283Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/468Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against 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)
  • 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)
CN202410035211.2A 2019-01-25 2020-01-24 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用 Pending CN117838856A (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201962796953P 2019-01-25 2019-01-25
US62/796,953 2019-01-25
CN202080016936.7A CN113614105A (zh) 2019-01-25 2020-01-24 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用
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)

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN202080016936.7A Division CN113614105A (zh) 2019-01-25 2020-01-24 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用

Publications (1)

Publication Number Publication Date
CN117838856A true CN117838856A (zh) 2024-04-09

Family

ID=69740563

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202410035211.2A Pending CN117838856A (zh) 2019-01-25 2020-01-24 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用
CN202080016936.7A Pending CN113614105A (zh) 2019-01-25 2020-01-24 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202080016936.7A Pending CN113614105A (zh) 2019-01-25 2020-01-24 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用

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
CA3024618A1 (en) 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
DK3658184T5 (da) 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer
CN118512588A (zh) 2017-10-26 2024-08-20 亚力兄制药公司 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用
EP3802593B1 (en) 2018-05-31 2024-09-11 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients
EP3802603A1 (en) 2018-06-04 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) in pediatric patients
US12312394B2 (en) 2018-06-28 2025-05-27 Alexion Pharmaceuticals, Inc. Methods of producing anti-C5 antibodies
EP3873602B1 (en) 2018-10-30 2023-12-06 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
EP4281472A1 (en) * 2021-01-22 2023-11-29 Alexion Pharmaceuticals, Inc. Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody
MX2023013148A (es) * 2021-05-07 2023-11-28 Novartis Ag Iptacopan para el tratamiento del sindrome uremico hemolitico atipico.

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
BR112017011235A2 (pt) 2014-12-19 2018-02-06 Chugai Pharmaceutical Co Ltd anticorpos anti-c5 e métodos de uso
EP3402816A1 (en) * 2016-01-11 2018-11-21 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
CN116769024A (zh) 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
DK3658184T5 (da) * 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer
CN118512588A (zh) * 2017-10-26 2024-08-20 亚力兄制药公司 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用
EP3802603A1 (en) * 2018-06-04 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) in pediatric patients

Also Published As

Publication number Publication date
JP2024120942A (ja) 2024-09-05
EP3914617A1 (en) 2021-12-01
AU2026200805A1 (en) 2026-02-26
AU2020213121A1 (en) 2021-08-12
LT3914617T (lt) 2024-05-27
CA3127797A1 (en) 2020-07-30
DK3914617T3 (da) 2024-05-27
JP2022518507A (ja) 2022-03-15
WO2020154626A1 (en) 2020-07-30
SI3914617T1 (sl) 2024-06-28
EP3914617B1 (en) 2024-03-13
JP7511566B2 (ja) 2024-07-05
AU2024266818B2 (en) 2026-02-19
HUE067202T2 (hu) 2024-10-28
MX2021008919A (es) 2021-11-04
JP7823117B2 (ja) 2026-03-03
PT3914617T (pt) 2024-05-31
AU2024266818A1 (en) 2025-01-02
KR20250016490A (ko) 2025-02-03
ES2980453T3 (es) 2024-10-01
PL3914617T3 (pl) 2024-08-05
FI3914617T3 (fi) 2024-05-24
US20220235121A1 (en) 2022-07-28
KR20210119420A (ko) 2021-10-05
CN113614105A (zh) 2021-11-05
BR112021014472A2 (pt) 2021-09-21

Similar Documents

Publication Publication Date Title
JP7823117B2 (ja) 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
JP7518764B2 (ja) 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
JP7577542B2 (ja) 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
US20190023775A1 (en) Dosage and administration of anti-c5 antibodies for treatment
JP2026026191A (ja) 造血幹細胞移植関連血栓性微小血管症(hsct-tma)を処置するための抗c5抗体の用量及び投与
RU2822664C2 (ru) ДОЗЫ И ВВЕДЕНИЕ АНТИТЕЛ ПРОТИВ C5 ДЛЯ ЛЕЧЕНИЯ АТИПИЧНОГО ГЕМОЛИТИКО-УРЕМИЧЕСКОГО СИНДРОМА (аГУС)
JP7734673B2 (ja) 抗c5抗体を使用して妊娠関連非典型溶血性尿毒症症候群を治療する方法
EA043233B1 (ru) ДОЗИРОВАНИЕ И ВВЕДЕНИЕ АНТИТЕЛ ПРОТИВ C5 ДЛЯ ЛЕЧЕНИЯ ПАЦИЕНТОВ С ПАРОКСИЗМАЛЬНОЙ НОЧНОЙ ГЕМОГЛОБИНУРИЕЙ (PNH) И АТИПИЧНЫМ ГЕМОЛИТИКО-УРЕМИЧЕСКИМ СИНДРОМОМ (aHUS)

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination