SI3914617T1 - Odmerjanje in dajanje protiteles proti-C5 za zdravljenje atipičnega hemolitično uremičnega sindroma (aHUS) - Google Patents

Odmerjanje in dajanje protiteles proti-C5 za zdravljenje atipičnega hemolitično uremičnega sindroma (aHUS)

Info

Publication number
SI3914617T1
SI3914617T1 SI202030425T SI202030425T SI3914617T1 SI 3914617 T1 SI3914617 T1 SI 3914617T1 SI 202030425 T SI202030425 T SI 202030425T SI 202030425 T SI202030425 T SI 202030425T SI 3914617 T1 SI3914617 T1 SI 3914617T1
Authority
SI
Slovenia
Prior art keywords
ahus
antibodies
dosage
administration
treatment
Prior art date
Application number
SI202030425T
Other languages
English (en)
Slovenian (sl)
Inventor
Lori Payton
Christian Mix
Rajendra Pradhan
Andrew Damokosh
Eugene Scott Swenson
Xiang Gao
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 SI3914617T1 publication Critical patent/SI3914617T1/sl

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    • 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

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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)
SI202030425T 2019-01-25 2020-01-24 Odmerjanje in dajanje protiteles proti-C5 za zdravljenje atipičnega hemolitično uremičnega sindroma (aHUS) SI3914617T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962796953P 2019-01-25 2019-01-25
EP20708762.8A EP3914617B1 (en) 2019-01-25 2020-01-24 Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus)
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
SI3914617T1 true SI3914617T1 (sl) 2024-06-28

Family

ID=69740563

Family Applications (1)

Application Number Title Priority Date Filing Date
SI202030425T SI3914617T1 (sl) 2019-01-25 2020-01-24 Odmerjanje in dajanje protiteles proti-C5 za zdravljenje atipičnega hemolitično uremičnega sindroma (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

Also Published As

Publication number Publication date
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
BR112021014472A2 (pt) 2021-09-21
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
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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