FI3284480T3 - IL-31-antagonistia vaikuttavana ainesosana sisältävä farmaseuttinen koostumus atooppisen ihottuman ehkäisemiseksi ja/tai hoitamiseksi - Google Patents

IL-31-antagonistia vaikuttavana ainesosana sisältävä farmaseuttinen koostumus atooppisen ihottuman ehkäisemiseksi ja/tai hoitamiseksi

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Publication number
FI3284480T3
FI3284480T3 FIEP16780054.9T FI16780054T FI3284480T3 FI 3284480 T3 FI3284480 T3 FI 3284480T3 FI 16780054 T FI16780054 T FI 16780054T FI 3284480 T3 FI3284480 T3 FI 3284480T3
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weeks
pharmaceutical composition
use according
topical
atopic dermatitis
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FIEP16780054.9T
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English (en)
Inventor
Akihisa Kaneko
Yuki Iwayanagi
Hidetomo Kitamura
Yoshinobu Higuchi
Hiroaki Matsushita
Ryosuke Mihara
Yumi Yamamoto
Tomohisa Saito
Keiko Hirokawa
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Chugai Pharmaceutical Co Ltd
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Publication of FI3284480T3 publication Critical patent/FI3284480T3/fi

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P37/08—Antiallergic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Neurology (AREA)
  • Endocrinology (AREA)
  • Pulmonology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)

Claims (9)

Patenttivaatimukset
1. Farmaseuttinen koostumus käytettäväksi atooppisen ihottuman eh- käisemisessä ja/tai hoitamisessa, koostumuksen käsittäessä vaikuttavana aineso- sana neutraloivaa anti-ihmis-IL-31RA-vasta-ainetta, jossa mainittu neutraloiva anti-ihmis-IL-31RA-vasta-aine on tarkoitettu annettavaksi ihonalaisesti minkä ta- hansa seuraavan kohdan (a) - (c) mukaisesti: (a) toistuvana antona yhtä suurina määrinä samalia annosteluvälillä kohteelle, jolla on tai saattaa olla atooppinen ihottuma, annoksella 25 - 100 mg/keho/4 viikkoa, 25 - 75 mg/keho/4 viikkoa, 50 - 100 mg/keho/4 viikkoa tai 50 -75mg/keho/d viikkoa; (b) toistuvana antona yhtä suurina määrinä samalla annosteluvalilla kohteelle, jolla on tai saattaa olla atooppinen ihottuma, annoksella 0,5 mg/kg/4 viikkoa; ja (c) aloitusannoksen antona ja sitä seuraavien jatkuvien annosten an- tona yhtä suurina määrinä samalla annosteluvälillä kohteelle annoksella 25 - 100 mg/keho/4 viikkoa, 25 - 75 mg/keho/4 viikkoa, 50 - 100 mg/keho/4 viikkoa tai 50 - 75 mg/keho/4 viikkoa, jossa aloitusannos eroaa jatkuvista annoksista; ja jossa mainittu neutraloiva anti-ihmis-IL-31RA-vasta-aine käsittää H- ketjun, joka on kuvattu sekvenssissä SEQ ID nro 9, ja L-ketjun, joka on kuvattu sek- —venssissä SEO ID nro 10.
2.Farmaseuttinen koostumus käytettäväksi patenttivaatimuksen 1 mu- kaisesti, jossa toistuva anto yhtä suurina määrinä samalla annosteluvälillä koh- dassa (a) on 25 - 75 mg/keho/4 viikkoa.
3. Farmaseuttinen koostumus käytettäväksi patenttivaatimuksen 1 mu- — kaisesti, jossa seuraavat jatkuvat annokset yhtä suurina määrinä samalla annoste- luvälillä kohdassa (c) ovat 25 - 75 mg/keho/4 viikkoa.
4. Farmaseuttinen koostumus käytettäväksi patenttivaatimuksen 1 tai 3 mukaisesti, jossa jatkuvat annokset kohdassa (c) on tarkoitettu annettavaksi an- noksella 0,5 mg/kg/4 viikkoa.
5. Farmaseuttinen koostumus käytettäväksi minkä tahansa patenttivaa- timuksen 1-4 mukaisesti atooppisen ihottuman aiheuttaman kutinan ehkäisemistä ja/tai hoitamista varten.
6. Farmaseuttinen koostumus käytettäväksi patenttivaatimuksen 5 mu- kaisesti kutinan aiheuttaman unihäiriön parantamista varten.
7. Farmaseuttinen koostumus käytettäväksi patenttivaatimuksen 6 mu- kaisesti, jossa unihäiriön parantaminen on nukahtamisesta heräämiseen kuluvan ajan pidentämistä ja/tai univiiveen (vuoteeseen menosta nukahtamiseen kuluvan ajan) lyhentämistä.
8. Farmaseuttinen koostumus käytettäväksi minkä tahansa patenttivaa- timuksen 1-7 mukaisesti, jossa mainittu käyttö tapahtuu yhdistelmänä paikalli- sesti annettavan steroidin tai paikallisesti annettavan kalsineuriinin estäjän kanssa, jossa neutraloiva anti-ihmis-IL-31RA-vasta-aine on tarkoitus antaa ennen paikallisesti annettavan steroidin tai paikallisesti annettavan kalsineuriinin estä- jän antoa, samanaikaisesti sen annon kanssa tai sen annon jälkeen.
9. Farmaseuttinen koostumus käytettäväksi patenttivaatimuksen 8 mu- — kaisesti, jossa paikallisesti annettavan steroidin tai paikallisesti annettavan kalsi- neuriinin estäjän anto yhdessä neutraloivan anti-ihmis-IL-31RA-vasta-aineen kanssa voi vähentää paikallisesti annettavan steroidin tai paikallisesti annettavan kaisineuriinin estäjän annostusta, kun sitä käytetään yhdistelmänä, verrattuna pai- kallisesti annettavan steroidin tai paikallisesti annettavan kalsineuriinin estäjän annostukseen, kun sitä annetaan jatkuvasti yksittäisenä aineena.
FIEP16780054.9T 2015-04-14 2016-04-13 IL-31-antagonistia vaikuttavana ainesosana sisältävä farmaseuttinen koostumus atooppisen ihottuman ehkäisemiseksi ja/tai hoitamiseksi FI3284480T3 (fi)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2015082699 2015-04-14
JP2016041641 2016-03-04
PCT/JP2016/061859 WO2016167263A1 (ja) 2015-04-14 2016-04-13 Ｉｌ－３１アンタゴニストを有効成分として含有する、アトピー性皮膚炎の予防用及び／又は治療用医薬組成物

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FI3284480T3 true FI3284480T3 (fi) 2025-09-11

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FIEP16780054.9T FI3284480T3 (fi) 2015-04-14 2016-04-13 IL-31-antagonistia vaikuttavana ainesosana sisältävä farmaseuttinen koostumus atooppisen ihottuman ehkäisemiseksi ja/tai hoitamiseksi
FIC20250033C FIC20250033I1 (fi) 2015-04-14 2025-10-22 nemolitsumabi

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US (3) US10544227B2 (fi)
EP (2) EP3284480B1 (fi)
JP (7) JP5954916B1 (fi)
KR (4) KR20170134748A (fi)
CN (2) CN114848823A (fi)
AU (2) AU2016248786B2 (fi)
BR (1) BR112017022101A2 (fi)
CA (1) CA2980992C (fi)
DK (1) DK3284480T3 (fi)
ES (1) ES3036076T3 (fi)
FI (2) FI3284480T3 (fi)
FR (1) FR25C1042I1 (fi)
HR (1) HRP20250972T1 (fi)
HU (2) HUE072989T2 (fi)
LT (2) LT3284480T (fi)
MA (1) MA43918A (fi)
MX (2) MX390570B (fi)
NL (1) NL301347I2 (fi)
NO (1) NO2025047I1 (fi)
PL (1) PL3284480T3 (fi)
PT (1) PT3284480T (fi)
RU (1) RU2749512C2 (fi)
SI (1) SI3284480T1 (fi)
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WO (1) WO2016167263A1 (fi)

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