HRP20160189T1 - Liječenje crohnove bolesti lakvinimodom - Google Patents

Liječenje crohnove bolesti lakvinimodom Download PDF

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Publication number
HRP20160189T1
HRP20160189T1 HRP20160189TT HRP20160189T HRP20160189T1 HR P20160189 T1 HRP20160189 T1 HR P20160189T1 HR P20160189T T HRP20160189T T HR P20160189TT HR P20160189 T HRP20160189 T HR P20160189T HR P20160189 T1 HRP20160189 T1 HR P20160189T1
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HR
Croatia
Prior art keywords
pharmaceutical composition
composition according
laquinimod
patient
disease
Prior art date
Application number
HRP20160189TT
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English (en)
Inventor
Nora Tarcic
Asi Haviv
Eran Blaugrund
Joel Kaye
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Teva Pharmaceutical Industries, Ltd.
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Application filed by Teva Pharmaceutical Industries, Ltd. filed Critical Teva Pharmaceutical Industries, Ltd.
Publication of HRP20160189T1 publication Critical patent/HRP20160189T1/hr

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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4704—2-Quinolinones, e.g. carbostyril
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/606—Salicylic acid; Derivatives thereof having amino groups
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/48—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
    • C07D215/54—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen attached in position 3
    • C07D215/56—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen attached in position 3 with oxygen atoms in position 4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Transplantation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (15)

1. Farmaceutski sastav za primjenu u liječenju pacijenta koji pati od Crohnove bolesti, naznačen time, da sadrži farmaceutski prihvatljiv nosilac i neku količinu lakvinimoda ili njegove farmaceutski prihvatljive soli, koji je učinkovit za liječenje pacijenta koji pati od Crohnove bolesti.
2. Farmaceutski sastav prema patentnom zahtjevu 1, naznačen time, da u biti sadrži jedan ili više farmaceutski prihvatljivih nosioca i neku količinu lakvinimoda ili njegove farmaceutski prihvatljive soli.
3. Farmaceutski sastav prema patentnom zahtjevu 1 ili 2, naznačen time, da količina lakvinimoda jest učinkovita da smanji simptom Crohnove bolesti kod pacijenta, da inducira klinički odgovor, da inducira ili održava kliničku remisiju, da inhibira progresiju bolesti ili da inhibira komplikaciju bolesti kod pacijenta.
4. Farmaceutski sastav prema patentnom zahtjevu 1 ili 2, naznačen time, da količina lakvinimoda jest učinkovita da smanji vrijednost indeksa aktivnosti Crohnove bolesti kod pacijenta, da smanji razinu C-reaktivnog proteina (CRP) kod pacijenta, da smanji razinu fekalnog kalprotektina kod pacijenta ili da smanji broj vanjskih fistula kod pacijenta.
5. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 4, naznačen time, da je pripremljen za oralno davanje.
6. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 5, naznačen time, da sadrži jediničnu dozu od 0,5 mg lakvinimoda ili njegove farmaceutski prihvatljive soli.
7. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 6, naznačen time, da je pripremljen za dnevno davanje.
8. Farmaceutski sastav prema patentnom zahtjevu 7, naznačen time, da je formuliran za davanje lakvinimoda ili njegove farmaceutski prihvatljive soli uz 0,5,- 2,0 mg dnevno.
9. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 8, naznačen time, da je pacijent imao aktivni umjereni do teški oblik Crohnove bolesti.
10. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 9, naznačen time, da je pacijent imao vrijednost indeksa aktivnosti Crohnove bolesti od 220 do 450.
11. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 10, naznačen time, da je pacijent imao razinu C-reaktivnog proteina iznad 5 mg/l.
12. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 11, naznačen time, da je pripremljen za davanje tijekom 8 tjedana ili više.
13. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1 - 12, naznačen time, da lakvinimod ili njegova farmaceutski prihvatljiva sol jest u obliku lakvinimod natrija.
14. Farmaceutski sastav, naznačen time, da u biti sadrži neku količinu lakvinimoda ili njegove farmaceutski prihvatljive soli, koja je učinkovita za liječenje pacijenta koji pati od Crohnove bolesti, te neku količinu 5-aminosalicilne kiseline, antibiotika, kortikosteroida, imunosupresivnih lijekova, TNFα agensa ili anti-integrina.
15. Primjena terapeutski učinkovite količine lakvinimoda ili njegove farmaceutski prihvatljive soli, naznačena time, da jest za proizvodnju lijeka za liječenje pacijenta koji pati od Crohnove bolesti.
HRP20160189TT 2009-07-30 2016-02-23 Liječenje crohnove bolesti lakvinimodom HRP20160189T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US27316709P 2009-07-30 2009-07-30
EP10804826.5A EP2458992B1 (en) 2009-07-30 2010-07-29 Treatment of crohn's disease with laquinimod

Publications (1)

Publication Number Publication Date
HRP20160189T1 true HRP20160189T1 (hr) 2016-05-20

Family

ID=43527240

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20160189TT HRP20160189T1 (hr) 2009-07-30 2016-02-23 Liječenje crohnove bolesti lakvinimodom

Country Status (22)

Country Link
US (8) US8598203B2 (hr)
EP (1) EP2458992B1 (hr)
JP (1) JP5882208B2 (hr)
KR (2) KR20120045032A (hr)
CN (2) CN102480960A (hr)
AU (3) AU2010276748A1 (hr)
BR (1) BR112012002124A2 (hr)
CA (1) CA2769623A1 (hr)
DK (1) DK2458992T3 (hr)
EA (1) EA025468B1 (hr)
ES (1) ES2564931T3 (hr)
HK (1) HK1171168A1 (hr)
HR (1) HRP20160189T1 (hr)
HU (1) HUE027680T2 (hr)
IL (1) IL217768A (hr)
ME (1) ME02414B (hr)
MX (1) MX2012001333A (hr)
PL (1) PL2458992T3 (hr)
RS (1) RS54707B1 (hr)
SI (1) SI2458992T1 (hr)
SM (1) SMT201600116B (hr)
WO (1) WO2011014255A1 (hr)

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