DK3220892T3 - Langtidsvirkende væksthormondoseringsformer - Google Patents

Langtidsvirkende væksthormondoseringsformer Download PDF

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Publication number
DK3220892T3
DK3220892T3 DK15798079.8T DK15798079T DK3220892T3 DK 3220892 T3 DK3220892 T3 DK 3220892T3 DK 15798079 T DK15798079 T DK 15798079T DK 3220892 T3 DK3220892 T3 DK 3220892T3
Authority
DK
Denmark
Prior art keywords
long
dosage forms
growth hormone
term growth
hormone dosage
Prior art date
Application number
DK15798079.8T
Other languages
English (en)
Inventor
Kennett Sprogøe
Henrik Egesborg
Steen Jensen
Thomas Kurpiers
Original Assignee
Ascendis Pharma Endocrinology Div A/S
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 Ascendis Pharma Endocrinology Div A/S filed Critical Ascendis Pharma Endocrinology Div A/S
Application granted granted Critical
Publication of DK3220892T3 publication Critical patent/DK3220892T3/da

Links

Classifications

    • 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
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/02Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
DK15798079.8T 2014-11-21 2015-11-20 Langtidsvirkende væksthormondoseringsformer DK3220892T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14194248 2014-11-21
PCT/EP2015/077229 WO2016079302A1 (en) 2014-11-21 2015-11-20 Long-acting growth hormone dosage forms

Publications (1)

Publication Number Publication Date
DK3220892T3 true DK3220892T3 (da) 2021-11-08

Family

ID=51945762

Family Applications (1)

Application Number Title Priority Date Filing Date
DK15798079.8T DK3220892T3 (da) 2014-11-21 2015-11-20 Langtidsvirkende væksthormondoseringsformer

Country Status (11)

Country Link
US (2) US12016903B2 (da)
EP (3) EP4732848A2 (da)
CY (1) CY1124734T1 (da)
DK (1) DK3220892T3 (da)
ES (1) ES2896971T3 (da)
HR (1) HRP20211734T8 (da)
HU (1) HUE056849T2 (da)
PL (1) PL3220892T3 (da)
PT (1) PT3220892T (da)
SI (1) SI3220892T1 (da)
WO (1) WO2016079302A1 (da)

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* Cited by examiner, † Cited by third party
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MX344559B (es) 2008-04-29 2016-12-20 Ascendis Pharma As Compuestos de hormona de crecimiento humana recombinante unidos al peg.
MX337432B (es) 2009-12-15 2016-03-04 Ascendis Pharma As Composicion de la hormona del crecimiento seca enlazada transitoriamente a un portador del polimero.
SG11201703870UA (en) 2014-11-18 2017-06-29 Ascendis Pharma Endocrinology Div As Novel polymeric hgh prodrugs
PT3220892T (pt) 2014-11-21 2021-11-05 Ascendis Pharma Endocrinology Div A/S Formas de dosagem de hormona do crescimento de longa ação
CN109152816B (zh) 2016-02-17 2022-08-16 株式会社吉耐森 用于治疗生长激素缺乏症的包含重组hgh的药物组合物
WO2018044060A1 (en) * 2016-08-30 2018-03-08 Genexine,Inc. PHARMACEUTICAL COMPOSITION FOR TREATING GROWTH HORMONE DEFICIENCY CONTAINING hGH FUSION PROTEIN
RU2748402C2 (ru) * 2016-08-30 2021-05-25 Дженексин,Инк. ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ТЕРАПИИ ДЕФИЦИТА ГОРМОНА РОСТА, СОДЕРЖАЩАЯ СЛИТЫЙ БЕЛОК hGH
AU2020233198B2 (en) * 2019-03-04 2025-05-15 Ascendis Pharma Endocrinology Division A/S Long-acting growth hormone dosage forms with superior efficacy to daily somatropin
WO2022197963A1 (en) * 2021-03-19 2022-09-22 Pfizer Inc. Long-acting growth hormone compositions
EP4308151A4 (en) * 2021-03-19 2025-02-26 Pfizer Inc. METHODS OF ADMINISTRATION OF LONG-ACTING GROWTH HORMONE POLYPEPTIDES
MX2024006318A (es) * 2021-11-26 2024-08-14 Genexine Inc Formulacion para administracion de alta concentracion de proteina de fusion de hormona del crecimiento.

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Also Published As

Publication number Publication date
PT3220892T (pt) 2021-11-05
HRP20211734T1 (hr) 2022-02-18
EP3220892A1 (en) 2017-09-27
PL3220892T3 (pl) 2022-01-31
WO2016079302A1 (en) 2016-05-26
HUE056849T2 (hu) 2022-03-28
HRP20211734T8 (hr) 2022-03-04
EP3988083A1 (en) 2022-04-27
US20170312342A1 (en) 2017-11-02
EP4732848A2 (en) 2026-04-29
EP3220892B1 (en) 2021-10-13
HK1244227A1 (zh) 2018-08-03
ES2896971T3 (es) 2022-02-28
US12016903B2 (en) 2024-06-25
US20240366730A1 (en) 2024-11-07
SI3220892T1 (sl) 2022-01-31
EP3988083B1 (en) 2026-03-11
CY1124734T1 (el) 2022-07-22

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