PL3658115T4 - Kompozycje w postaci wodnego roztworu do wstrzykiwań zawierające co najmniej insulinę ludzką a21g i co najmniej jeden supresor glukagonu o działaniu prandialnym - Google Patents

Kompozycje w postaci wodnego roztworu do wstrzykiwań zawierające co najmniej insulinę ludzką a21g i co najmniej jeden supresor glukagonu o działaniu prandialnym

Info

Publication number
PL3658115T4
PL3658115T4 PL18746942.4T PL18746942T PL3658115T4 PL 3658115 T4 PL3658115 T4 PL 3658115T4 PL 18746942 T PL18746942 T PL 18746942T PL 3658115 T4 PL3658115 T4 PL 3658115T4
Authority
PL
Poland
Prior art keywords
compositions
aqueous solution
human insulin
injectable aqueous
prandial action
Prior art date
Application number
PL18746942.4T
Other languages
English (en)
Other versions
PL3658115T3 (pl
Inventor
You-Ping Chan
Original Assignee
Adocia
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
Priority claimed from FR1757172A external-priority patent/FR3069436A1/fr
Priority claimed from FR1757184A external-priority patent/FR3069437A1/fr
Priority claimed from FR1855250A external-priority patent/FR3082426A1/fr
Application filed by Adocia filed Critical Adocia
Publication of PL3658115T4 publication Critical patent/PL3658115T4/pl
Publication of PL3658115T3 publication Critical patent/PL3658115T3/pl

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
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • 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
    • 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
    • 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
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/62Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
PL18746942.4T 2017-07-27 2018-07-27 Kompozycje w postaci wodnego roztworu do wstrzykiwań zawierające co najmniej insulinę ludzką a21g i co najmniej jeden supresor glukagonu o działaniu prandialnym PL3658115T3 (pl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
FR1757172A FR3069436A1 (fr) 2017-07-27 2017-07-27 Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
FR1757184A FR3069437A1 (fr) 2017-07-28 2017-07-28 Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
FR1855250A FR3082426A1 (fr) 2018-06-14 2018-06-14 Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
PCT/EP2018/070510 WO2019020820A2 (fr) 2017-07-27 2018-07-27 Compositions sous forme d'une solution aqueuse injectable comprenant au moins l'insuline humaine a21g et un suppresseur de glucagon a action prandiale

Publications (2)

Publication Number Publication Date
PL3658115T4 true PL3658115T4 (pl) 2022-08-08
PL3658115T3 PL3658115T3 (pl) 2022-08-08

Family

ID=63047385

Family Applications (2)

Application Number Title Priority Date Filing Date
PL22156880.1T PL4019039T3 (pl) 2017-07-27 2018-07-27 Kompozycje w postaci wodnego roztworu do wstrzykiwania zawierające co najmniej insulinę ludzką a21g i co najmniej jeden supresor glukagonu o działaniu posiłkowym
PL18746942.4T PL3658115T3 (pl) 2017-07-27 2018-07-27 Kompozycje w postaci wodnego roztworu do wstrzykiwań zawierające co najmniej insulinę ludzką a21g i co najmniej jeden supresor glukagonu o działaniu prandialnym

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PL22156880.1T PL4019039T3 (pl) 2017-07-27 2018-07-27 Kompozycje w postaci wodnego roztworu do wstrzykiwania zawierające co najmniej insulinę ludzką a21g i co najmniej jeden supresor glukagonu o działaniu posiłkowym

Country Status (16)

Country Link
US (2) US10610572B2 (pl)
EP (2) EP3658115B1 (pl)
JP (2) JP7240004B2 (pl)
KR (1) KR20200034779A (pl)
CN (1) CN110996905A (pl)
AU (2) AU2018308692A1 (pl)
BR (1) BR112020001617A2 (pl)
CA (1) CA3071064A1 (pl)
DK (1) DK4019039T3 (pl)
ES (2) ES2969277T3 (pl)
IL (1) IL272141B1 (pl)
MA (1) MA49678A (pl)
PH (1) PH12020500122A1 (pl)
PL (2) PL4019039T3 (pl)
SG (1) SG11202000625PA (pl)
WO (1) WO2019020820A2 (pl)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201607918D0 (en) 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
EP3658115B1 (fr) * 2017-07-27 2022-02-23 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant au moins l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
FR3082426A1 (fr) * 2018-06-14 2019-12-20 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
EP3915572A1 (en) 2020-05-29 2021-12-01 Adocia Pharmaceutical composition in the form of an injectable aqueous solution including at least a rapid acting insulin analog and a glucagon suppressor with prandial action
EP3915571A1 (en) 2020-05-29 2021-12-01 Adocia Pharmaceutical composition in the form of an injectable aqueous solution including at least a rapid acting insulin analog and a glucagon suppressor with prandial action
EP4144362A1 (en) * 2021-09-06 2023-03-08 Adocia Compositions comprising short-acting hormones for treating or preventing obesity and pumps comprising said composition
EP4129324A1 (en) * 2021-08-02 2023-02-08 Adocia Compositions comprising at least an amylin receptor agonist and a glp-1 receptor agonist
EP4342486A1 (en) 2022-09-20 2024-03-27 Adocia Compositions comprising at least an insulin and an amylin receptor agonist for treating diabetes, in a patient/person having a bmi of more than 28 kg/m² and/or an hba1c of more than 7.6 %

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5008241A (en) 1985-03-12 1991-04-16 Novo Nordisk A/S Novel insulin peptides
CA1295330C (en) 1985-03-29 1992-02-04 James M. Greene Synthesis of inotropic imidazo(4,5-c) pyridine
GB8720115D0 (en) 1987-08-26 1987-09-30 Cooper G J S Treatment of diabetes mellitus
US5234906A (en) 1991-01-10 1993-08-10 Amylin Pharmaceuticals, Inc. Hyperglycemic compositions
HU222249B1 (hu) 1991-03-08 2003-05-28 Amylin Pharmaceuticals Inc. Eljárás amilin agonista peptidszármazékok és ezeket tartalmazó gyógyszerkészítmények előállítására
ZA946881B (en) 1993-09-07 1995-10-30 Amylin Pharmaceuticals Inc Methods for treating gastrointestinal motility
US6410511B2 (en) 1997-01-08 2002-06-25 Amylin Pharmaceuticals, Inc. Formulations for amylin agonist peptides
US7312196B2 (en) 1997-01-08 2007-12-25 Amylin Pharmaceuticals, Inc. Formulations for amylin agonist peptides
US6506724B1 (en) 1999-06-01 2003-01-14 Amylin Pharmaceuticals, Inc. Use of exendins and agonists thereof for the treatment of gestational diabetes mellitus
EP1076066A1 (en) 1999-07-12 2001-02-14 Zealand Pharmaceuticals A/S Peptides for lowering blood glucose levels
JP5312054B2 (ja) * 2006-03-15 2013-10-09 ノボ・ノルデイスク・エー/エス アミリンとインスリンの混合物
WO2007135118A1 (en) 2006-05-24 2007-11-29 Novo Nordisk A/S Soluble, stable insulin-containing formulations
WO2008124522A2 (en) 2007-04-04 2008-10-16 Biodel, Inc. Amylin formulations
WO2009004627A2 (en) 2007-07-02 2009-01-08 Medingo Ltd. A device for drug delivery
EP2200635A1 (en) * 2007-09-11 2010-06-30 Novo Nordisk A/S Mixture comprising an amylin peptide and a protracted insulin
EP2060268A1 (en) 2007-11-15 2009-05-20 Novo Nordisk A/S Pharmaceutical compositions for pulmonary or nasal delivery of peptides
AU2011202239C1 (en) * 2010-05-19 2017-03-16 Sanofi Long-acting formulations of insulins
JP6117811B2 (ja) * 2011-10-31 2017-04-19 ゼリス ファーマシューティカルズ インコーポレイテッド 糖尿病を処置するための製剤
US20150174209A1 (en) 2012-05-25 2015-06-25 Amylin Pharmaceuticals. Llc Insulin-pramlintide compositions and methods for making and using them
RU2016107610A (ru) * 2013-09-30 2017-11-03 Вокхардт Лимитед Фармацевтическая композиция
SI3229828T1 (sl) * 2014-12-12 2023-06-30 Sanofi-Aventis Deutschland Gmbh Formulacija s fiksnim razmerjem inzulin glargin/liksisenatid
EP3658115B1 (fr) * 2017-07-27 2022-02-23 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant au moins l'insuline humaine a21g et un suppresseur de glucagon a action prandiale

Also Published As

Publication number Publication date
WO2019020820A2 (fr) 2019-01-31
DK4019039T3 (da) 2024-01-15
PL4019039T3 (pl) 2024-03-18
WO2019020820A3 (fr) 2019-03-28
ES2917893T3 (es) 2022-07-12
ES2969277T3 (es) 2024-05-17
JP2020528439A (ja) 2020-09-24
IL272141B1 (en) 2024-03-01
JP2023078143A (ja) 2023-06-06
US20200188487A1 (en) 2020-06-18
US10610572B2 (en) 2020-04-07
BR112020001617A2 (pt) 2020-07-21
US20190054149A1 (en) 2019-02-21
JP7240004B2 (ja) 2023-03-15
EP3658115B1 (fr) 2022-02-23
AU2023202831A1 (en) 2023-05-25
PL3658115T3 (pl) 2022-08-08
AU2018308692A1 (en) 2020-03-05
KR20200034779A (ko) 2020-03-31
MA49678A (fr) 2021-04-14
EP4019039A1 (fr) 2022-06-29
US11065305B2 (en) 2021-07-20
EP3658115A2 (fr) 2020-06-03
SG11202000625PA (en) 2020-02-27
EP4019039B1 (fr) 2023-10-11
CA3071064A1 (fr) 2019-01-31
IL272141A (en) 2020-03-31
PH12020500122A1 (en) 2020-09-14
CN110996905A (zh) 2020-04-10

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