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CY1124734T1 - Μορφες δοσολογιας αυξητικης ορμονικης μακρας δρασης - Google Patents

Μορφες δοσολογιας αυξητικης ορμονικης μακρας δρασης

Info

Publication number
CY1124734T1
CY1124734T1 CY20211100999T CY211100999T CY1124734T1 CY 1124734 T1 CY1124734 T1 CY 1124734T1 CY 20211100999 T CY20211100999 T CY 20211100999T CY 211100999 T CY211100999 T CY 211100999T CY 1124734 T1 CY1124734 T1 CY 1124734T1
Authority
CY
Cyprus
Prior art keywords
growth hormone
long
dosage forms
acting
acting growth
Prior art date
Application number
CY20211100999T
Other languages
English (en)
Inventor
Henrik EGESBORG
Steen Jensen
Thomas Kurpiers
Kennett Sprogøe
Original Assignee
Ascendis Pharma Endocrinology Division 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 Division A/S filed Critical Ascendis Pharma Endocrinology Division A/S
Publication of CY1124734T1 publication Critical patent/CY1124734T1/el

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Η παρούσα εφεύρεση σχετίζεται με μια φαρμακευτική σύνθεση που περιλαμβάνει μια αυξητική ορμόνη μακράς δράσης για χρήση σε μια μέθοδο θεραπείας της έλλειψης αυξητικής ορμόνης, όπου το σκεύασμα αυξητικής ορμόνης μακράς δράσης χορηγείται σε έναν ασθενή σε ένα δοσολογικό σχήμα με κατηγορίες, σε ένα πλήθος από μορφές μοναδιαίας δοσολογίας που περιλαμβάνουν μια σύνθεση αυξητικής ορμόνης μακράς δράσης, όπου οι μορφές μοναδιαίας δοσολογίας περιλαμβάνουν αυξανόμενες ποσότητες ισοδύναμων αυξητικής ορμόνης και όπου η ποσότητα των ισοδύναμων αυξητικής ορμόνης αυξάνεται κατά τουλάχιστον 10% μεταξύ μιας μορφής μοναδιαίας δοσολογίας και της επόμενης υψηλότερης μορφής δοσολογίας, με τη χρήση σε μια μέθοδο αντιμετώπισης της έλλειψης αυξητικής ορμόνης και μέθοδο αντιμετώπισης της έλλειψης αυξητικής ορμόνης σε ένα δοσολογικό σχήμα με κατηγορίες.
CY20211100999T 2014-11-21 2021-11-18 Μορφες δοσολογιας αυξητικης ορμονικης μακρας δρασης CY1124734T1 (el)

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
CY1124734T1 true CY1124734T1 (el) 2022-07-22

Family

ID=51945762

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20211100999T CY1124734T1 (el) 2014-11-21 2021-11-18 Μορφες δοσολογιας αυξητικης ορμονικης μακρας δρασης

Country Status (12)

Country Link
US (2) US12016903B2 (el)
EP (2) EP3988083A1 (el)
CY (1) CY1124734T1 (el)
DK (1) DK3220892T3 (el)
ES (1) ES2896971T3 (el)
HK (1) HK1244227A1 (el)
HR (1) HRP20211734T8 (el)
HU (1) HUE056849T2 (el)
PL (1) PL3220892T3 (el)
PT (1) PT3220892T (el)
SI (1) SI3220892T1 (el)
WO (1) WO2016079302A1 (el)

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PL3416677T3 (pl) 2016-02-17 2022-11-21 Genexine, Inc. Kompozycja farmaceutyczna obejmująca rekombinowany hgh do leczenia niedoboru hormonu wzrostu
JOP20190019A1 (ar) * 2016-08-30 2019-02-12 Genexine Inc تركيبة صيدلانية لعلاج نقص في هرمون نمو يحتوي على بروتين اندماجي لهرمون نمو بشري (hGH)
WO2018044060A1 (en) * 2016-08-30 2018-03-08 Genexine,Inc. PHARMACEUTICAL COMPOSITION FOR TREATING GROWTH HORMONE DEFICIENCY CONTAINING hGH FUSION PROTEIN
US12303553B2 (en) 2019-03-04 2025-05-20 Ascendis Pharma Endocrinology Division A/S Long-acting growth hormone dosage forms with superior efficacy to daily somatropin
WO2022197961A1 (en) * 2021-03-19 2022-09-22 Pfizer Inc. Methods of administering long-acting growth hormone polypeptides
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US20250026804A1 (en) * 2021-11-16 2025-01-23 Genexine, Inc. High-concentration administration formulation of hgh fusion protein

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Also Published As

Publication number Publication date
US20170312342A1 (en) 2017-11-02
DK3220892T3 (da) 2021-11-08
ES2896971T3 (es) 2022-02-28
US20240366730A1 (en) 2024-11-07
US12016903B2 (en) 2024-06-25
EP3220892A1 (en) 2017-09-27
HK1244227A1 (zh) 2018-08-03
PT3220892T (pt) 2021-11-05
WO2016079302A1 (en) 2016-05-26
PL3220892T3 (pl) 2022-01-31
HRP20211734T1 (hr) 2022-02-18
HUE056849T2 (hu) 2022-03-28
SI3220892T1 (sl) 2022-01-31
EP3988083A1 (en) 2022-04-27
EP3220892B1 (en) 2021-10-13
HRP20211734T8 (hr) 2022-03-04

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