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FI3225243T3 - Menetelmä sekundaarisen hyperparatyreoosin turvalliseen ja tehokkaaseen hoitoon ja ehkäisyyn kroonisen munuaistaudin yhteydessä - Google Patents

Menetelmä sekundaarisen hyperparatyreoosin turvalliseen ja tehokkaaseen hoitoon ja ehkäisyyn kroonisen munuaistaudin yhteydessä

Info

Publication number
FI3225243T3
FI3225243T3 FIEP17158264.6T FI17158264T FI3225243T3 FI 3225243 T3 FI3225243 T3 FI 3225243T3 FI 17158264 T FI17158264 T FI 17158264T FI 3225243 T3 FI3225243 T3 FI 3225243T3
Authority
FI
Finland
Prior art keywords
vitamin
hydroxy
composition
patient
stage
Prior art date
Application number
FIEP17158264.6T
Other languages
English (en)
Inventor
Charles Bishop
Eric Messner
Original Assignee
Opko Renal Llc
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 Opko Renal Llc filed Critical Opko Renal Llc
Application granted granted Critical
Publication of FI3225243T3 publication Critical patent/FI3225243T3/fi

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • A61P5/20—Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Nutrition Science (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (12)

Patenttivaatimukset
1. Koostumus, joka käsittää 25-hydroksi-D3-vitamiinia ja valinnaisesti 25-hydroksi-D2- vitamiinia, käytettäväksi vaiheen 3-5 kroonista munuaistautia (CKD) sairastavan ihmispotilaan sekundaarisen hyperparatyreoosin ylläpito-/ennaltaehkäisyhoidossa, jolloin — potilas on tunnettu epänormaalisti kohonneista lisäkilpirauhashormonin veripitoisuuksista siten, että hän tarvitsee hoitoa saavuttaakseen kroonisen munuaistaudin (CKD) vaihekohtaiset iPTH-tavoitealueet, jotka ovat vaiheessa 3 35—70 pg/ml, vaiheessa 4 70-110 pg/ml ja vaiheessa 5 150-300 pg/ml, menetelmällä, joka käsittää sekä potilaan 25-hydroksi-D-vitamiinin että 1,25-dihydroksi-D-vitamiinin veripitoisuuksien nostamisen tai ylläpitämisen siten, että 25- — hydroksi-D3-vitamiini on vallitseva prohormoni verenkierrossa, jolloin mainittu 25- dihydroksi-D-vitamiiniyhdiste(et) annetaan siten, että potilaan seerumin lisäkilpirauhashormonin pitoisuus laskee CKD:n tavoitealueelle ja jolloin koostumus annetaan potilaalle suun kautta annettavana tai laskimonsisäisenä annosformulaationa 0,5-100 ug:n yksikköannosmuodossa, ja antaminen tapahtuu episodisesti vaihdellen päivittäisestä — antamisesta 1-3 kertaan viikossa, jolloin annos on 0,5—400 ug viikossa, siten, että potilaan seerumin lisäkilpirauhashormonipitoisuus laskee CKD:n tavoitealueelle.
2. Koostumus, joka käsittää 25-hydroksi-D3-vitamiinia ja valinnaisesti 25-hydroksi-D2- vitamiinia ja lisäksi valinnaisesti tarpeen mukaan 1,25-dihydroksi-D2-vitamiinia, käytettäväksi vaiheen 3-5 kroonista —munuaistautia — sairastavan — ihmispotilaan — sekundaarisen — hyperparatyreoosin ylläpito-/ennaltaehkäisyhoidossa, jolloin potilas on tunnettu epänormaalisti kohonneista lisäkilpirauhashormonin veripitoisuuksista siten, että hän tarvitsee hoitoa saavuttaakseen kroonisen munuaistaudin vaihekohtaiset iPTH- tavoitealueet, jotka ovat vaiheessa 3 35—70 pg/ml, vaiheessa 4 70-110 pg/ml ja vaiheessa 5 150-300 pg/ml, jolloin koostumus annetaan siten, että 25-hydroksi-D-vitamiinin — veripitoisuudet nousevat vähintään pitoisuuteen 30 ng/ml ja pysyvät siinä tai korkeammassa pitoisuudessa niin, että 25-hydroksi-D3-vitamiini on vallitseva prohormoni, ja 1,25-dihydroksi- D-vitamiinin veripitoisuudet nousevat potilaan normaalille 1,25-dihydroksi-D-vitamiinin historialliselle fysiologiselle alueelle tai pysyvät sen sisällä, ja kohonneet plasman iPTH- pitoisuudet laskevat tai pysyvät kontrollissa samalla välttäen epänormaalin alhaisen luun — vaihtuvuusnopeuden, ja jolloin mainittu 25-hydroksi-D-vitamiiniyhdiste(et) annetaan siten, että potilaan seerumin lisäkilpirauhashormonipitoisuus laskee CKD:n tavoitealueelle, ja jolloin koostumus — annetaan — potilaalle suun kautta annettavana tai laskimonsisäisenä annosformulaationa 0,5-100 ug:n yksikköannosmuodossa, ja antaminen tapahtuu episodisesti vaihdellen päivittäisestä antamisesta 1-3 kertaan viikossa, jolloin annos on 0,5-400 pg viikossa, siten, että potilaan seerumin lisäkilpirauhashormonipitoisuus laskee CKD:n tavoitealueelle.
3. Koostumus patenttivaatimuksen 1 mukaiseen käyttöön, joka käsittää mainit(t)u(je)n 25- hydroksi-D-vitamiiniyhdiste(id)en antamisen siten, että 25-hydroksi-D-vitamiinin pitoisuudet — veressä nousevat vähintään pitoisuuteen 30 ng/ml ja pysyvät siinä tai korkeammassa pitoisuudessa.
4. Koostumus jonkin edellisen patenttivaatimuksen mukaiseen käyttöön, joka käsittää mainit(t)u(je)n 25-hydroksi-D-vitamiiniyhdiste(id)en antamisen siten, että 25-hydroksi-D- vitamiinin pitoisuudet veressä pysyvät vähintään pitoisuudessa 30 ng/ml vähintään 30 päivän — ajan.
5. Koostumus jonkin edellisen patenttivaatimuksen mukaiseen käyttöön, joka käsittää mainit(t)u(je)n 25-hydroksi-D-vitamiiniyhdiste(id)en antamisen siten, että 25-hydroksi-D- vitamiinin pitoisuudet veressä pysyvät vähintään pitoisuudessa 30 ng/ml vähintään 2 kuukauden ajan.
6. Koostumus jonkin edellisen patenttivaatimuksen mukaiseen käyttöön, joka käsittää mainit(t)u(je)n 25-hydroksi-D-vitamiiniyhdiste(id)en antamisen siten, että potilaan seerumin lisäkilpirauhashormonin pitoisuus laskee vähintään 30 % hoitoa edeltävään tilaan verrattuna.
7. Koostumus jonkin edellisen patenttivaatimuksen mukaiseen käyttöön, joka käsittää lisäksi 1,25-dihydroksi-D2-vitamiinin antamisen potilaalle D-vitamiinihormonikorvaushoitona.
— 8. Koostumus jonkin edellisen patenttivaatimuksen mukaiseen käyttöön, jolloin potilaalla on vaiheen 3 tai 4 krooninen munuaistauti.
9. Koostumus jonkin edellisen patenttivaatimuksen mukaiseen käyttöön, jolloin potilaalla on vaiheen 5 krooninen munuaistauti.
10. Koostumus jonkin patenttivaatimuksen 1-7 mukaiseen käyttöön, jolloin koostumusta — annetaan potilaalle 1-3 kertaa viikossa.
11. Koostumus jonkin patenttivaatimuksen 1-7 mukaiseen käyttöön, jolloin koostumus on pitkävaikutteinen formulaatio.
12. Koostumus jonkin edellisen patenttivaatimuksen mukaiseen käyttöön, joka käsittää mainit(t)u(je)n 25-hydroksi-D-vitamiiniyhdiste(id)en antamisen siten, että vältetään plasman —iPTH:n liikatuotanto.
FIEP17158264.6T 2007-04-25 2008-04-25 Menetelmä sekundaarisen hyperparatyreoosin turvalliseen ja tehokkaaseen hoitoon ja ehkäisyyn kroonisen munuaistaudin yhteydessä FI3225243T3 (fi)

Applications Claiming Priority (1)

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US91385007P 2007-04-25 2007-04-25

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FI3225243T3 true FI3225243T3 (fi) 2025-10-13

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Family Applications (2)

Application Number Title Priority Date Filing Date
FIEP18155042.7T FI3335712T3 (fi) 2007-04-25 2008-04-25 Menetelmä sekundaarisen hyperparatyreoosin turvalliseen ja tehokkaaseen hoitoon ja ehkäisyyn kroonisen munuaistaudin yhteydessä
FIEP17158264.6T FI3225243T3 (fi) 2007-04-25 2008-04-25 Menetelmä sekundaarisen hyperparatyreoosin turvalliseen ja tehokkaaseen hoitoon ja ehkäisyyn kroonisen munuaistaudin yhteydessä

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Country Status (10)

Country Link
US (3) US20100144684A1 (fi)
EP (3) EP3225243B1 (fi)
JP (5) JP2010525080A (fi)
CA (1) CA2683514C (fi)
DK (2) DK3225243T3 (fi)
ES (2) ES3047207T3 (fi)
FI (2) FI3335712T3 (fi)
PT (2) PT3335712T (fi)
SI (1) SI3225243T1 (fi)
WO (1) WO2008134523A1 (fi)

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