MX382443B - Una formulación estable para usarse en el tratamiento de la enfermedad por leucodistrofia metacromática (mld). - Google Patents

Una formulación estable para usarse en el tratamiento de la enfermedad por leucodistrofia metacromática (mld).

Info

Publication number
MX382443B
MX382443B MX2017000156A MX2017000156A MX382443B MX 382443 B MX382443 B MX 382443B MX 2017000156 A MX2017000156 A MX 2017000156A MX 2017000156 A MX2017000156 A MX 2017000156A MX 382443 B MX382443 B MX 382443B
Authority
MX
Mexico
Prior art keywords
treatment
stable formulation
metachromatic leukodystrophy
mld
leukodystrophy disease
Prior art date
Application number
MX2017000156A
Other languages
English (en)
Inventor
Pericles Calias
Paul Campolieto
Lawrence Charnas
Jing Pan
Nazila Salamat-Miller
Zahra Shahrokh
Katherine Taylor
Teresa Leah Wright
Original Assignee
Shire Human Genetic Therapies
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 Shire Human Genetic Therapies filed Critical Shire Human Genetic Therapies
Publication of MX382443B publication Critical patent/MX382443B/es

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)
    • 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)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0085—Brain, e.g. brain implants; Spinal cord
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Psychology (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Psychiatry (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Hospice & Palliative Care (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se refiere, entre otras cosas, a composiciones y métodos para suministro al CNS de enzimas lisosomales para tratamiento efectivo de enfermedades de almacenamiento lisosomal; en algunas modalidades, la presente invención incluye una formulación estable para administración intratecal directa al CNS que comprende una proteína arilsulfatasa A (ASA), sal, y un tensoactivo de polisorbato para el tratamiento de Enfermedad de Leucodistrofia Metacromática.
MX2017000156A 2010-06-25 2011-06-25 Una formulación estable para usarse en el tratamiento de la enfermedad por leucodistrofia metacromática (mld). MX382443B (es)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US35885710P 2010-06-25 2010-06-25
US36078610P 2010-07-01 2010-07-01
US38786210P 2010-09-29 2010-09-29
US201161435710P 2011-01-24 2011-01-24
US201161442115P 2011-02-11 2011-02-11
US201161476210P 2011-04-15 2011-04-15
US201161495268P 2011-06-09 2011-06-09
PCT/US2011/041926 WO2011163650A2 (en) 2010-06-25 2011-06-25 Methods and compositions for cns delivery of arylsulfatase a

Publications (1)

Publication Number Publication Date
MX382443B true MX382443B (es) 2025-03-11

Family

ID=46888844

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2013000323A MX344795B (es) 2010-06-25 2011-06-25 Composiciones y metodos para suministro al sistema nervioso central de arilsulfatasa a.
MX2017000156A MX382443B (es) 2010-06-25 2011-06-25 Una formulación estable para usarse en el tratamiento de la enfermedad por leucodistrofia metacromática (mld).

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2013000323A MX344795B (es) 2010-06-25 2011-06-25 Composiciones y metodos para suministro al sistema nervioso central de arilsulfatasa a.

Country Status (26)

Country Link
US (1) US9770410B2 (es)
EP (3) EP3964230A1 (es)
JP (1) JP6045493B2 (es)
KR (5) KR102318997B1 (es)
CN (1) CN103282046B (es)
AU (5) AU2011270670B2 (es)
BR (1) BR112012033216B1 (es)
CA (1) CA2803003C (es)
CY (2) CY1122282T1 (es)
DK (1) DK2585104T3 (es)
ES (1) ES2754776T3 (es)
HR (1) HRP20191923T1 (es)
IL (3) IL291556B2 (es)
LT (1) LT2585104T (es)
ME (1) ME03647B (es)
MX (2) MX344795B (es)
NZ (2) NZ605873A (es)
PL (2) PL2585104T3 (es)
RS (1) RS59468B1 (es)
RU (1) RU2671503C2 (es)
SI (1) SI2585104T1 (es)
SM (1) SMT201900589T1 (es)
TW (1) TWI667037B (es)
UA (1) UA115650C2 (es)
WO (1) WO2011163650A2 (es)
ZA (1) ZA201300675B (es)

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Publication number Publication date
AU2017202289B2 (en) 2019-03-14
ES2754776T3 (es) 2020-04-20
AU2017202289A1 (en) 2017-04-27
EP3626257A1 (en) 2020-03-25
KR20180059580A (ko) 2018-06-04
JP6045493B2 (ja) 2016-12-14
MX2013000323A (es) 2013-06-05
UA115650C2 (uk) 2017-12-11
CA2803003A1 (en) 2011-12-29
CN103282046B (zh) 2015-05-13
RU2671503C2 (ru) 2018-11-01
KR101997935B1 (ko) 2019-10-04
US20120009171A1 (en) 2012-01-12
WO2011163650A3 (en) 2013-06-13
KR20210131449A (ko) 2021-11-02
IL273854B (en) 2022-04-01
IL291556B1 (en) 2023-10-01
PL3626257T3 (pl) 2022-03-28
KR20230079472A (ko) 2023-06-07
ME03647B (me) 2020-07-20
DK2585104T3 (da) 2019-10-14
BR112012033216A2 (pt) 2020-08-25
CY1122282T1 (el) 2020-11-25
WO2011163650A2 (en) 2011-12-29
EP3626257B1 (en) 2021-08-04
EP2585104B1 (en) 2019-08-21
KR20130135821A (ko) 2013-12-11
IL273854A (en) 2020-05-31
AU2021236557A1 (en) 2021-10-28
CN103282046A (zh) 2013-09-04
IL291556B2 (en) 2024-02-01
LT2585104T (lt) 2019-10-25
AU2019204051B2 (en) 2021-07-22
HRP20191923T1 (hr) 2020-01-10
KR102720061B1 (ko) 2024-10-22
JP2013538788A (ja) 2013-10-17
TWI667037B (zh) 2019-08-01
BR112012033216B1 (pt) 2022-10-11
RS59468B1 (sr) 2019-11-29
EP3964230A1 (en) 2022-03-09
TW201206464A (en) 2012-02-16
AU2025202376A1 (en) 2025-04-24
RU2012154574A (ru) 2014-07-27
KR20200035167A (ko) 2020-04-01
PL2585104T3 (pl) 2020-01-31
KR102094094B1 (ko) 2020-03-27
AU2011270670B2 (en) 2017-01-12
KR102318997B1 (ko) 2021-10-29
ZA201300675B (en) 2017-11-29
IL223758B (en) 2020-04-30
AU2021236557B2 (en) 2025-01-30
CY1124910T1 (el) 2023-01-05
US9770410B2 (en) 2017-09-26
MX344795B (es) 2017-01-05
EP2585104A4 (en) 2014-01-15
CA2803003C (en) 2022-11-22
NZ702799A (en) 2016-08-26
EP2585104A2 (en) 2013-05-01
SI2585104T1 (sl) 2019-11-29
KR102537084B1 (ko) 2023-05-26
IL291556A (en) 2022-05-01
NZ605873A (en) 2015-02-27
AU2019204051A1 (en) 2019-08-29
SMT201900589T1 (it) 2020-03-13
AU2011270670A1 (en) 2013-02-14

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