CO2021006290A2 - Dosificación subcutánea y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxistica nocturna (pnh) - Google Patents

Dosificación subcutánea y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxistica nocturna (pnh)

Info

Publication number
CO2021006290A2
CO2021006290A2 CONC2021/0006290A CO2021006290A CO2021006290A2 CO 2021006290 A2 CO2021006290 A2 CO 2021006290A2 CO 2021006290 A CO2021006290 A CO 2021006290A CO 2021006290 A2 CO2021006290 A2 CO 2021006290A2
Authority
CO
Colombia
Prior art keywords
pnh
administration
treatment
paroxysmal nocturnal
nocturnal hemoglobinuria
Prior art date
Application number
CONC2021/0006290A
Other languages
English (en)
Inventor
Douglas L Sheridan
Rajendra Pradhan
Xiang Gao
Lori Volles
Marc Vallee
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 CO2021006290A2 publication Critical patent/CO2021006290A2/es

Links

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
    • 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
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • 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
    • C07K2317/90—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

RESUMEN Se proporcionan métodos para el tratamiento clínico de la hemoglobinuria paroxística nocturna (PNH) que comprenden administrar al paciente un anticuerpo anti-C5, o un fragmento de unión al antígeno de este, donde el anticuerpo anti-C5, o fragmento de unión al antígeno de este, se administra (o es para administración) subcutáneamente de acuerdo con un régimen de dosificación clínico particular (es decir, en una cantidad de dosis particular y de acuerdo con un programa de dosificación específico). En una realización, el paciente ha sido tratado previamente con eculizumab (Soliris®).
CONC2021/0006290A 2018-10-30 2021-05-13 Dosificación subcutánea y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxistica nocturna (pnh) CO2021006290A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862752563P 2018-10-30 2018-10-30
PCT/US2019/058846 WO2020092549A1 (en) 2018-10-30 2019-10-30 Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)

Publications (1)

Publication Number Publication Date
CO2021006290A2 true CO2021006290A2 (es) 2021-06-10

Family

ID=68621358

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2021/0006290A CO2021006290A2 (es) 2018-10-30 2021-05-13 Dosificación subcutánea y administración de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxistica nocturna (pnh)

Country Status (13)

Country Link
US (1) US20210395352A1 (es)
EP (2) EP3873602B1 (es)
JP (2) JP2022512632A (es)
KR (1) KR20210084533A (es)
CN (1) CN112996561A (es)
AU (1) AU2019370295A1 (es)
BR (1) BR112021008063A2 (es)
CA (1) CA3118282A1 (es)
CO (1) CO2021006290A2 (es)
EA (1) EA202191189A1 (es)
IL (1) IL281990A (es)
MX (1) MX2021004994A (es)
WO (1) WO2020092549A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116194478A (zh) * 2020-06-24 2023-05-30 阿雷克森制药公司 皮下（sc）施用抗c5抗体治疗补体相关病症
EP4281472A1 (en) * 2021-01-22 2023-11-29 Alexion Pharmaceuticals, Inc. Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody

Family Cites Families (14)

* 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
JP5815403B2 (ja) 2008-08-05 2015-11-17 ノバルティス アーゲー 補体タンパク質ｃ５を標的とする抗体に関する組成物および方法
US8883979B2 (en) * 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
WO2014099546A1 (en) 2012-12-19 2014-06-26 Promerus, Llc Process for the preparation of high purity norbornene alkanols and derivatives thereof
NZ711451A (en) * 2014-03-07 2016-05-27 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
KR102515796B1 (ko) 2014-12-19 2023-03-30 추가이 세이야쿠 가부시키가이샤 항-c5 항체 및 그의 사용 방법
US20190135903A1 (en) * 2015-03-31 2019-05-09 Alexion Pharmaceuticals, Inc. Identifying and treating subpopulations of paroxysmal nocturnal hemoglobinuria (pnh) patients
JP6650042B2 (ja) * 2015-12-27 2020-02-19 アッヴィ・インコーポレイテッド 装着型自動注射装置ならびに関連する組立方法および使用方法
US20190023775A1 (en) * 2016-01-11 2019-01-24 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
AU2017283470B2 (en) 2016-06-14 2024-03-21 Regeneron Pharmaceuticals, Inc. Anti-C5 antibodies and uses thereof
SI3658184T1 (sl) * 2017-07-27 2024-01-31 Alexion Pharmaceuticals, Inc., Formulacije z visoko koncentracijo protiteles proti-C5
KR20200070355A (ko) * 2017-10-26 2020-06-17 알렉시온 파마슈티칼스, 인코포레이티드 발작성 야간 혈색소뇨 (pnh) 및 비정형 용혈성 요독 증후군 (ahus)의 치료를 위한 항-c5 항체의 투여량 및 투여
EP3802593A1 (en) * 2018-05-31 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients

Also Published As

Publication number Publication date
CA3118282A1 (en) 2020-05-07
CN112996561A (zh) 2021-06-18
EA202191189A1 (ru) 2021-08-06
WO2020092549A1 (en) 2020-05-07
EP3873602A1 (en) 2021-09-08
AU2019370295A1 (en) 2021-06-03
KR20210084533A (ko) 2021-07-07
IL281990A (en) 2021-05-31
BR112021008063A2 (pt) 2021-08-10
JP2022512632A (ja) 2022-02-07
JP2024015045A (ja) 2024-02-01
MX2021004994A (es) 2021-06-15
EP4306128A3 (en) 2024-03-27
EP3873602B1 (en) 2023-12-06
EP4306128A2 (en) 2024-01-17
US20210395352A1 (en) 2021-12-23

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