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HRP20240823T1 - Farmaceutski pripravak, namijenjen upotrebi u liječenju ili sprječavanju bolesti povezane s c5 i postupak liječenja ili sprječavanja bolesti povezane s c5 - Google Patents

Farmaceutski pripravak, namijenjen upotrebi u liječenju ili sprječavanju bolesti povezane s c5 i postupak liječenja ili sprječavanja bolesti povezane s c5 Download PDF

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Publication number
HRP20240823T1
HRP20240823T1 HRP20240823TT HRP20240823T HRP20240823T1 HR P20240823 T1 HRP20240823 T1 HR P20240823T1 HR P20240823T T HRP20240823T T HR P20240823TT HR P20240823 T HRP20240823 T HR P20240823T HR P20240823 T1 HRP20240823 T1 HR P20240823T1
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HR
Croatia
Prior art keywords
phase
subcutaneous
pharmaceutical preparation
administration
dose
Prior art date
Application number
HRP20240823TT
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English (en)
Inventor
Kenji SHINOMIYA
Keisuke GOTANDA
Jun-ichi NISHIMURA
Erica WINTER
Joy C. HSU
Original Assignee
Chugai Seiyaku Kabushiki Kaisha
F. Hoffmann-La Roche Ag
Osaka University
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.)
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Publication date
Application filed by Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche Ag, Osaka University filed Critical Chugai Seiyaku Kabushiki Kaisha
Publication of HRP20240823T1 publication Critical patent/HRP20240823T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • 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
    • 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
    • C07K2317/24Immunoglobulins 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
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • 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

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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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (2)

1. Farmaceutski pripravak, formuliran za supkutanu injekciju koja sadrži protutijelo protiv C5, koji sadrži VH slijed SEQ ID NO: 2 i VL slijed SEQ ID NO: 6, naznačen time što je namijenjen upotrebi u postupku liječenja ili sprječavanja bolesti povezane s C5, koju se bira iz skupine koju čine reumatoidni artritis (RA); lupozni nefritis; ishemijsko-reperfuzijska ozljeda; paroksiumalna noćna hemoglobinurija (PNH), atipični hemolitički uremijski sindrom (aHUS), bolest gustih naslaga (DDD); degeneracija makule; hemoliza, povišeni jetreni enzimi, te sindrom niskih trombocita (HELLP); trombotska trombocitopenična purpura (UP); spontani gubitak fetusa; oligoimuni vaskulitis; bulozna epidermoliza; recidivirajući gubitak fetusa; multipla skleroza (MS); traumatska ozljeda mozga; ozljeda koja je posljedica infarkta miokarda, kardiopulmonalna premosnica ili hemodijaliza; refraktorna generalizirana miastenija gravis (gMG), te neuromijelitis očnog živca (NMO), gdje se pripravak supkutano primijenjuje u dvije faze nakon primjene farmaceutskog pripravka formuliranog za intravensku injekciju koja sadrži protutijelo protiv C5, gdje u obje faze supkutanih primjena postoji interval između svake dvije supkutane primjene, gdje svaka faza sadrži najmanje jedan interval, gdje je doza protutijela intravenske primjene 1000 mg, gdje se prvu supkutanu primjenu prve faze primijenjuje 0 do 8 dana nakon konačne primjene intravenski primijenjenog farmaceutskog pripravka, gdje je doza protutijela u supkutanoj primjeni prve faze 170 mg ili 340 mg, gdje se farmaceutski pripravak primijenjuje u prvoj fazi jednom svakog tjedna (tjedno), te gdje se farmaceutski pripravak namijenjen supkutana primjena primijenjuje u drugoj fazi četiri puta tjedno, u dozi od 680 mg.
2. Farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što je broj supkutanih primjena u prvoj fazi 1 do 12.
HRP20240823TT 2018-08-01 2019-08-01 Farmaceutski pripravak, namijenjen upotrebi u liječenju ili sprječavanju bolesti povezane s c5 i postupak liječenja ili sprječavanja bolesti povezane s c5 HRP20240823T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862713211P 2018-08-01 2018-08-01
US201862764952P 2018-08-17 2018-08-17
US201862760204P 2018-11-13 2018-11-13
EP19755447.0A EP3829628B1 (en) 2018-08-01 2019-08-01 A pharmaceutical composition for use in the treatment or prevention of a c5-related disease
PCT/JP2019/030283 WO2020027279A1 (en) 2018-08-01 2019-08-01 A pharmaceutical composition for use in the treatment or prevention of a c5-related disease and a method for treating or preventing a c5-related disease

Publications (1)

Publication Number Publication Date
HRP20240823T1 true HRP20240823T1 (hr) 2024-09-27

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HRP20240823TT HRP20240823T1 (hr) 2018-08-01 2019-08-01 Farmaceutski pripravak, namijenjen upotrebi u liječenju ili sprječavanju bolesti povezane s c5 i postupak liječenja ili sprječavanja bolesti povezane s c5

Country Status (21)

Country Link
US (1) US20210301004A1 (hr)
EP (2) EP3829628B1 (hr)
JP (3) JP6672516B2 (hr)
KR (5) KR20210038697A (hr)
CN (1) CN112512563A (hr)
AU (2) AU2019315213B2 (hr)
BR (1) BR112021001655A2 (hr)
CA (1) CA3107618A1 (hr)
CR (1) CR20210103A (hr)
DE (1) DE112019003835T5 (hr)
ES (1) ES2980137T3 (hr)
HR (1) HRP20240823T1 (hr)
HU (1) HUE067057T2 (hr)
IL (1) IL280475A (hr)
MX (1) MX2021000516A (hr)
PH (1) PH12021550226A1 (hr)
PL (1) PL3829628T3 (hr)
RS (1) RS65630B1 (hr)
SG (1) SG10202002898RA (hr)
TW (2) TWI704157B (hr)
WO (1) WO2020027279A1 (hr)

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JP2020073608A (ja) 2020-05-14
US20210301004A1 (en) 2021-09-30
EP4445913A2 (en) 2024-10-16
CN112512563A (zh) 2021-03-16
ES2980137T3 (es) 2024-09-30
RS65630B1 (sr) 2024-07-31
BR112021001655A2 (pt) 2021-05-04
AU2024205486A1 (en) 2024-08-22
KR20210038697A (ko) 2021-04-07
TW202024128A (zh) 2020-07-01
PH12021550226A1 (en) 2021-10-11
CA3107618A1 (en) 2020-02-06
EP3829628C0 (en) 2024-05-15
JP2020019769A (ja) 2020-02-06
IL280475A (en) 2021-03-01
CR20210103A (es) 2021-03-22
AU2019315213A1 (en) 2021-03-25
JP2020079331A (ja) 2020-05-28
TWI701041B (zh) 2020-08-11
KR20200033225A (ko) 2020-03-27
DE112019003835T5 (de) 2021-05-27
KR20200033348A (ko) 2020-03-27
JP6672533B1 (ja) 2020-03-25
KR20210037743A (ko) 2021-04-06
HUE067057T2 (hu) 2024-09-28
EP3829628A1 (en) 2021-06-09
TW202019467A (zh) 2020-06-01
AU2019315213B2 (en) 2024-05-02
WO2020027279A1 (en) 2020-02-06
SG10202002898RA (en) 2020-05-28
KR20240115904A (ko) 2024-07-26
EP3829628B1 (en) 2024-05-15
PL3829628T3 (pl) 2024-08-19
JP6672516B2 (ja) 2020-03-25
TWI704157B (zh) 2020-09-11
MX2021000516A (es) 2021-04-12

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