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FI3515937T3 - Refraktaarisen migreenin hoito - Google Patents

Refraktaarisen migreenin hoito

Info

Publication number
FI3515937T3
FI3515937T3 FIEP17785013.8T FI17785013T FI3515937T3 FI 3515937 T3 FI3515937 T3 FI 3515937T3 FI 17785013 T FI17785013 T FI 17785013T FI 3515937 T3 FI3515937 T3 FI 3515937T3
Authority
FI
Finland
Prior art keywords
monoclonal antibody
group
subject
migraine
use according
Prior art date
Application number
FIEP17785013.8T
Other languages
English (en)
Inventor
Marcelo Bigal
Ernesto Aycardi
Original Assignee
Teva Pharmaceuticals Int Gmbh
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=60120094&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=FI3515937(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceuticals Int Gmbh filed Critical Teva Pharmaceuticals Int Gmbh
Application granted granted Critical
Publication of FI3515937T3 publication Critical patent/FI3515937T3/fi

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (6)

EP3515937 1 Patenttivaatimukset
1. Monoklonaalinen vasta-aine, joka käsittää sekvenssin SEO ID NO:11 esittämän raskasketjun täyden vasta-aineen aminohapposekvenssin ja sekvenssin SEO ID NO:12 —esittämän kevytketjun täyden vasta-aineen aminohapposekvenssin, — käytettäväksi menetelmässä sellaisen hoidettavan migreenin hoitamiseksi, joka ei saa suotuisaa hoitovastetta vähintään kahteen ennaltaehkäisevään migreenihoitoon, jolloin kukin ennaltaehkäisevä migreenihoito valitaan eri ryhmästä, jolloin ryhmät määritellään seuraavasti: ryhmä A: propranololi, metoprololi, atenololi ja bisopropoli ryhmä B: topiramaatti ryhmä C: amitriptyliini ryhmä D: flunaritsiini ryhmä E: kandesartaani ryhmä F: onabotuliinitoksiini A ja ryhmä G: valproiinihappo.
2. Monoklonaalinen vasta-aine patenttivaatimuksen 1 mukaiseen käyttöön, jolloin (i) hoidettava ei saa suotuisaa vastetta migreenin ennaltaehkäisevään hoitoon kolmen kuukauden kuluessa ja/tai hänellä ilmenee haittavaikutuksia ja/tai (ii) yksi migreenin ennaltaehkäisevistä hoidoista on onabotuliinitoksiini A eikä hoidettava saa suotuisaa vastetta onabotuliinitoksiini A -hoitoon kuuden kuukauden kuluessa ja/tai hänellä ilmenee haittavaikutuksia.
3. Monoklonaalinen vasta-aine patenttivaatimuksen 1 mukaiseen käyttöön, jolloin hoidettava ei saa suotuisaa vastetta kahteen tai kolmeen eri ryhmiin kuuluvaan ennaltaehkäisevään migreenihoitoon.
4. Monoklonaalinen vasta-aine patenttivaatimuksen 1 mukaiseen käyttöön, jolloin menetelmä käsittää vasta-aineen antamisen hoidettavalle esitäytetystä ruiskusta, — esitäytetystä ruiskusta, jossa on turvaneulalaite, injektiokynästä tai autoinjektorista, joka käsittää yhden annoksen monoklonaalista vasta-ainetta.
EP3515937 2
5. Monoklonaalinen vasta-aine patenttivaatimuksen 1 mukaiseen käyttöön, jolloin hoidettava on ihminen.
6. Monoklonaalinen vasta-aine patenttivaatimuksen 1 mukaiseen käyttöön, jolloin menetelmä käsittää toisen aineen antamisen hoidettavalle samanaikaisesti tai peräkkäin monoklonaalisen vasta-aineen kanssa, jolloin kyseinen toinen aine on lääke akuutin päänsäryn hoitoon, jolloin valinnaisesti hoidettavan toisen aineen kuukausittainen käyttö vähenee vähintään 15% monoklonaalisen vasta-aineen antamisen jälkeen.
FIEP17785013.8T 2016-09-23 2017-09-22 Refraktaarisen migreenin hoito FI3515937T3 (fi)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662399180P 2016-09-23 2016-09-23
US201762558557P 2017-09-14 2017-09-14
PCT/IB2017/055777 WO2018055574A1 (en) 2016-09-23 2017-09-22 Treating refractory migraine

Publications (1)

Publication Number Publication Date
FI3515937T3 true FI3515937T3 (fi) 2026-02-11

Family

ID=60120094

Family Applications (1)

Application Number Title Priority Date Filing Date
FIEP17785013.8T FI3515937T3 (fi) 2016-09-23 2017-09-22 Refraktaarisen migreenin hoito

Country Status (17)

Country Link
US (7) US10392434B2 (fi)
EP (2) EP3515937B1 (fi)
JP (3) JP6937368B2 (fi)
KR (2) KR20220031944A (fi)
CN (1) CN109952314A (fi)
AU (2) AU2017331593B2 (fi)
BR (1) BR112019005823A2 (fi)
CA (1) CA3036632A1 (fi)
CL (1) CL2019000760A1 (fi)
FI (1) FI3515937T3 (fi)
IL (1) IL265343A (fi)
LT (1) LT3515937T (fi)
MX (1) MX2019003337A (fi)
PE (1) PE20191148A1 (fi)
SG (1) SG10201913032TA (fi)
WO (1) WO2018055574A1 (fi)
ZA (1) ZA201901531B (fi)

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