CA3029887A1 - Subcutaneous administration of long-acting factor ix in humans - Google Patents

Subcutaneous administration of long-acting factor ix in humans Download PDF

Info

Publication number
CA3029887A1
CA3029887A1 CA3029887A CA3029887A CA3029887A1 CA 3029887 A1 CA3029887 A1 CA 3029887A1 CA 3029887 A CA3029887 A CA 3029887A CA 3029887 A CA3029887 A CA 3029887A CA 3029887 A1 CA3029887 A1 CA 3029887A1
Authority
CA
Canada
Prior art keywords
days
fix
dose
fusion protein
dosing interval
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
CA3029887A
Other languages
English (en)
French (fr)
Inventor
Christine VOIGT
Shilpa PULI
John Roberts
Marc Nolte
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.)
CSL Behring Lengnau AG
Original Assignee
CSL Behring Lengnau AG
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 CSL Behring Lengnau AG filed Critical CSL Behring Lengnau AG
Publication of CA3029887A1 publication Critical patent/CA3029887A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
CA3029887A 2016-07-08 2017-07-07 Subcutaneous administration of long-acting factor ix in humans Pending CA3029887A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662359745P 2016-07-08 2016-07-08
US62/359745 2016-07-08
PCT/EP2017/067127 WO2018007601A1 (en) 2016-07-08 2017-07-07 Subcutaneous administration of long-acting factor ix in humans

Publications (1)

Publication Number Publication Date
CA3029887A1 true CA3029887A1 (en) 2018-01-11

Family

ID=59388044

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3029887A Pending CA3029887A1 (en) 2016-07-08 2017-07-07 Subcutaneous administration of long-acting factor ix in humans

Country Status (11)

Country Link
US (1) US20200093901A1 (enExample)
EP (2) EP3481416B1 (enExample)
JP (1) JP6971301B2 (enExample)
KR (1) KR102446476B1 (enExample)
CN (1) CN109843319A (enExample)
AU (1) AU2017294555B2 (enExample)
CA (1) CA3029887A1 (enExample)
DK (1) DK3481416T3 (enExample)
ES (1) ES2832648T3 (enExample)
PL (1) PL3481416T3 (enExample)
WO (1) WO2018007601A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4362971A1 (en) * 2021-07-01 2024-05-08 CSL Behring Lengnau AG Factor ix subcutaneous administration with enhanced safety

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL113010A (en) 1994-03-31 1999-10-28 Pharmacia & Upjohn Ab Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration
CA2405550A1 (en) * 2000-04-12 2001-10-25 Human Genome Sciences, Inc. Albumin fusion proteins
US7939632B2 (en) 2006-06-14 2011-05-10 Csl Behring Gmbh Proteolytically cleavable fusion proteins with high molar specific activity
CN103140237A (zh) 2010-07-09 2013-06-05 比奥根艾迪克依蒙菲利亚公司 因子ix多肽及其使用方法
TW201427685A (zh) * 2012-09-25 2014-07-16 Biogen Idec Inc Fix多肽的應用
EP3082848B1 (en) * 2013-12-06 2023-10-18 Bioverativ Therapeutics Inc. Population pharmacokinetics tools and uses thereof
CA2934081A1 (en) * 2013-12-23 2015-07-02 Csl Limited Fusion proteins comprising factor ix for prophylactic treatment of hemophilia and methods thereof

Also Published As

Publication number Publication date
CN109843319A (zh) 2019-06-04
AU2017294555B2 (en) 2022-04-28
KR20190026863A (ko) 2019-03-13
DK3481416T3 (da) 2020-12-14
AU2017294555A1 (en) 2019-02-21
ES2832648T3 (es) 2021-06-10
EP3481416A1 (en) 2019-05-15
JP6971301B2 (ja) 2021-11-24
US20200093901A1 (en) 2020-03-26
EP3733199A1 (en) 2020-11-04
KR102446476B1 (ko) 2022-10-19
PL3481416T3 (pl) 2021-03-22
JP2019524089A (ja) 2019-09-05
WO2018007601A1 (en) 2018-01-11
EP3481416B1 (en) 2020-09-09

Similar Documents

Publication Publication Date Title
TWI810729B (zh) Fix多肽的應用
KR20160016756A (ko) Adamts13의 피하 투여
US20160346366A1 (en) Fusion proteins comprising factor ix for prophylactic treatment of hemophilia and methods thereof
AU2017294555B2 (en) Subcutaneous administration of long-acting factor IX in humans
ES2966835T3 (es) Modulación de la inmunogenicidad del FVIII por VWF truncado
US20240293516A1 (en) Factor ix subcutaneous administration with enhanced safety
HK40039380A (en) Subcutaneous administration of long-acting factor ix in humans
HK40007789A (en) Subcutaneous administration of long-acting factor ix in humans
HK40007789B (en) Subcutaneous administration of long-acting factor ix in humans
AU2018294517B2 (en) 21-day dosing regimen for fusion proteins comprising factor IX and human albumin for prophylactic treatment of hemophilia and methods thereof
WO2023246680A1 (en) Activators of coagulation factor x and formulations thereof for treating bleeding disorders
US20170042981A1 (en) Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor
HK40027732B (en) 21-day dosing regimen for fusion proteins comprising factor ix and human albumin for prophylactic treatment of hemophilia and methods thereof

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220705

EEER Examination request

Effective date: 20220705

EEER Examination request

Effective date: 20220705

EEER Examination request

Effective date: 20220705