DK2968434T3 - C1-INH-sammensætninger til anvendelse til forebyggelse og behandling af arvelig angioødem (HAE). - Google Patents

C1-INH-sammensætninger til anvendelse til forebyggelse og behandling af arvelig angioødem (HAE). Download PDF

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DK2968434T3
DK2968434T3 DK14762343.3T DK14762343T DK2968434T3 DK 2968434 T3 DK2968434 T3 DK 2968434T3 DK 14762343 T DK14762343 T DK 14762343T DK 2968434 T3 DK2968434 T3 DK 2968434T3
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esterase inhibitor
composition
use according
hae
units
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DK14762343.3T
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Cynthia Gallagher
Mark Cornell Manning
Stephen Ruddy
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Shire Viropharma Inc
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    • 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
    • A61K38/55—Protease inhibitors
    • A61K38/57—Protease inhibitors from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
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    • A—HUMAN NECESSITIES
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    • 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
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • A61K38/55—Protease inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
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    • 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
    • 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
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/81—Protease inhibitors

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  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
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Claims (13)

1. Sammensætning omfattende mindst en Cl-esteraseinhibitor hvor den mindst ene Cl-esteraseinhibitor er til stede i 400U/ml eller mere til anvendelse til behandling, inhibering eller forebyggelse af arvelig angioødem (HAE), og hvor sammensætningen indgives subkutant.
2. Sammensætning til anvendelse ifølge krav 1, hvor den mindst ene Cl-esteraseinhibitor er til stede i op til 500 U/ml.
3. Sammensætning ifølge krav 1 eller krav 2, hvor den mindst ene Cl-esteraseinhibitor indgives i en dosis der varierer fra 500 units til ca. 5.000 units, 1.000 units til 3.500 units eller 1.500 units til 2.500 units.
4. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den mindst ene Cl-esteraseinhibitor indgives dagligt, hver anden dag, hver tredje dag, en gang om ugen, to gange om ugen eller tre gange om ugen.
5. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor individet indgives en høj startdosis af den mindst ene Cl-esteraseinhibitor, efterfulgt af mindre vedligeholdelsesdoser, eventuelt hvor den høje startdosis er mindst 1,5, 2, 3, 4 eller 5 gange de efterfølgende doser, og/eller den høje startdosis indgives intravenøst, og den mindst ene Cl-esteraseinhibitor efterfølgende indgives subkutant.
6. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor indgivelsen af den mindst ene Cl-esteraseinhibitor fører til øgede niveauer af Cl-esteraseinhibitoren i individets blod, hvor blodniveauerne af Cl-esteraseinhibitor øges til mindst 0,3 U/ml, 0,4 U/ml eller op til 1 U/ml.
7. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor blodniveauerne af Cl-esteraseinhibitor fastholdes ved eller over 0,4 U/ml i mindst 50%, mindst 75%, mindst 90% eller mindst 95% af tiden.
8. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor: (i) det arvelige angioødem er Type I eller Type II HAE, (ii) indgivelsen af den mindst ene Cl-esteraseinhibitor resulterer i HAE profylaktisk behandling, (iii) behandling af HAE resulterer i mindst en reduktion af graden og/eller antallet af HAE-anfald, eller (iv) indgivelsen af den mindst ene Cl-esteraseinhibitor resulterer i behandling af et HAE-anfald.
9. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor den mindst ene Cl-esteraseinhibitor er isoleret eller oprenset fra humant plasma eller er fremstillet rekombinant, og/eller hvor Cl-esteraseinhibitoren har en aminosyresekvens der er mindst 90%, 95%, 98%, 99% eller 100% identisk med den humane Cl-esteraseinhibitor-aminosyresekvens i figur 1.
10. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor sammensætningen omfatter en buffer, der omfatter citrat eller natriumcitrat, eventuelt 5mM til 50 mM natriumcitrat, 10 mM til 30 mM natriumcitrat eller 20 mM natriumcitrat.
11. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-9, omfattende en buffer hvor bufferen ikke indeholder citrat eller citronsyre.
12. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor sammensætningen: (i) omfatter mindst en aminosyre eller et salt deraf; og/eller (ii) har en pH-værdi på mellem 6,5 og 8,0.
13. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav hvor sammensætningen dannes fra en lyofiliseret form ved rekonstituering i en buffer inden indgivelse.
DK14762343.3T 2013-03-15 2014-03-17 C1-INH-sammensætninger til anvendelse til forebyggelse og behandling af arvelig angioødem (HAE). DK2968434T3 (da)

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US201361791399P 2013-03-15 2013-03-15
PCT/US2014/030309 WO2014145519A2 (en) 2013-03-15 2014-03-17 C1-inh compositions and methods for the prevention and treatment of disorders associated with c1 esterase inhibitor deficency

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DK2968434T3 true DK2968434T3 (da) 2017-09-11

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DK14762343.3T DK2968434T3 (da) 2013-03-15 2014-03-17 C1-INH-sammensætninger til anvendelse til forebyggelse og behandling af arvelig angioødem (HAE).

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