AU2017294555B2 - Subcutaneous administration of long-acting factor IX in humans - Google Patents

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

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Publication number
AU2017294555B2
AU2017294555B2 AU2017294555A AU2017294555A AU2017294555B2 AU 2017294555 B2 AU2017294555 B2 AU 2017294555B2 AU 2017294555 A AU2017294555 A AU 2017294555A AU 2017294555 A AU2017294555 A AU 2017294555A AU 2017294555 B2 AU2017294555 B2 AU 2017294555B2
Authority
AU
Australia
Prior art keywords
fix
dose
days
human
once
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.)
Ceased
Application number
AU2017294555A
Other languages
English (en)
Other versions
AU2017294555A1 (en
Inventor
Marc Nolte
Shilpa PULI
John Roberts
Christine VOIGT
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 AU2017294555A1 publication Critical patent/AU2017294555A1/en
Application granted granted Critical
Publication of AU2017294555B2 publication Critical patent/AU2017294555B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • A61K38/385—Serum albumin
    • 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

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)
AU2017294555A 2016-07-08 2017-07-07 Subcutaneous administration of long-acting factor IX in humans Ceased AU2017294555B2 (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 (2)

Publication Number Publication Date
AU2017294555A1 AU2017294555A1 (en) 2019-02-21
AU2017294555B2 true AU2017294555B2 (en) 2022-04-28

Family

ID=59388044

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2017294555A Ceased AU2017294555B2 (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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
A J GERRARD ET AL.: "Subcutaneous injection of factor IX for the treatment of haemophilia B", 《BR J HAEMATOL》 *

Also Published As

Publication number Publication date
CN109843319A (zh) 2019-06-04
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
CA3029887A1 (en) 2018-01-11
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

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired