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 PDFInfo
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- 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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- pharmaceutical preparation
- administration
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- 201000010099 disease Diseases 0.000 title claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title claims 2
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 230000002265 prevention Effects 0.000 title claims 2
- 238000007920 subcutaneous administration Methods 0.000 claims 6
- 239000000825 pharmaceutical preparation Substances 0.000 claims 5
- 208000035913 Atypical hemolytic uremic syndrome Diseases 0.000 claims 2
- 208000004451 Membranoproliferative Glomerulonephritis Diseases 0.000 claims 2
- 208000000733 Paroxysmal Hemoglobinuria Diseases 0.000 claims 2
- 102100036050 Phosphatidylinositol N-acetylglucosaminyltransferase subunit A Human genes 0.000 claims 2
- 208000022401 dense deposit disease Diseases 0.000 claims 2
- 231100000562 fetal loss Toxicity 0.000 claims 2
- 201000006417 multiple sclerosis Diseases 0.000 claims 2
- 206010028417 myasthenia gravis Diseases 0.000 claims 2
- 201000003045 paroxysmal nocturnal hemoglobinuria Diseases 0.000 claims 2
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 claims 1
- 108090000790 Enzymes Proteins 0.000 claims 1
- 206010014989 Epidermolysis bullosa Diseases 0.000 claims 1
- 206010018910 Haemolysis Diseases 0.000 claims 1
- 208000005777 Lupus Nephritis Diseases 0.000 claims 1
- 206010063837 Reperfusion injury Diseases 0.000 claims 1
- 206010043561 Thrombocytopenic purpura Diseases 0.000 claims 1
- 201000007023 Thrombotic Thrombocytopenic Purpura Diseases 0.000 claims 1
- 208000030886 Traumatic Brain injury Diseases 0.000 claims 1
- 206010047115 Vasculitis Diseases 0.000 claims 1
- 208000027418 Wounds and injury Diseases 0.000 claims 1
- 230000002612 cardiopulmonary effect Effects 0.000 claims 1
- 230000006378 damage Effects 0.000 claims 1
- 238000001631 haemodialysis Methods 0.000 claims 1
- 230000000322 hemodialysis Effects 0.000 claims 1
- 230000008588 hemolysis Effects 0.000 claims 1
- 208000014674 injury Diseases 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 238000010253 intravenous injection Methods 0.000 claims 1
- 208000012947 ischemia reperfusion injury Diseases 0.000 claims 1
- 210000004185 liver Anatomy 0.000 claims 1
- 208000002780 macular degeneration Diseases 0.000 claims 1
- 208000010125 myocardial infarction Diseases 0.000 claims 1
- 210000001328 optic nerve Anatomy 0.000 claims 1
- 230000000306 recurrent effect Effects 0.000 claims 1
- 230000002269 spontaneous effect Effects 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
- 239000007929 subcutaneous injection Substances 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 230000009529 traumatic brain injury Effects 0.000 claims 1
- 230000003442 weekly effect Effects 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- 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
- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
-
- 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
-
- 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
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
Landscapes
- 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.
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 |
Family
ID=67660420
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101479381B (zh) | 2006-03-31 | 2015-04-29 | 中外制药株式会社 | 调控抗体血液动力学的方法 |
| AU2008304778B9 (en) | 2007-09-26 | 2014-05-08 | Chugai Seiyaku Kabushiki Kaisha | Method of modifying isoelectric point of antibody via amino acid substitution in CDR |
| PT2275443E (pt) | 2008-04-11 | 2016-03-15 | Chugai Pharmaceutical Co Ltd | Moléculas de ligação ao antigénio capazes de se ligarem, repetidamente, a duas ou mais moléculas de antigénio |
| CN103328632A (zh) | 2010-11-30 | 2013-09-25 | 中外制药株式会社 | 与多分子的抗原重复结合的抗原结合分子 |
| PL3233921T3 (pl) | 2014-12-19 | 2022-01-10 | Chugai Seiyaku Kabushiki Kaisha | Przeciwciała anty-c5 i sposoby ich stosowania |
| AU2017305073B2 (en) | 2016-08-05 | 2024-02-01 | Chugai Seiyaku Kabushiki Kaisha | Composition for prevention or treatment of IL-8 related diseases |
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| PL220113B1 (pl) | 1999-01-15 | 2015-08-31 | Genentech Inc | Wariant macierzystego polipeptydu zawierającego region Fc, polipeptyd zawierający wariant regionu Fc o zmienionym powinowactwie wiązania receptora Fc gamma (FcγR), polipeptyd zawierający wariant regionu Fc o zmienionym powinowactwie wiązania noworodkowego receptora Fc (FcRn), kompozycja, wyizolowany kwas nukleinowy, wektor, komórka gospodarza, sposób otrzymywania wariantu polipeptydu, zastosowanie wariantu polipeptydu i sposób otrzymywania wariantu regionu Fc |
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| ITMI20021527A1 (it) | 2002-07-11 | 2004-01-12 | Consiglio Nazionale Ricerche | Anticorpi anti componente c5 del complemento e loro uso |
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| PT2275443E (pt) | 2008-04-11 | 2016-03-15 | Chugai Pharmaceutical Co Ltd | Moléculas de ligação ao antigénio capazes de se ligarem, repetidamente, a duas ou mais moléculas de antigénio |
| AU2009279197B2 (en) | 2008-08-05 | 2013-12-12 | Novartis Ag | Compositions and methods for antibodies targeting complement protein C5 |
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| PL3233921T3 (pl) * | 2014-12-19 | 2022-01-10 | Chugai Seiyaku Kabushiki Kaisha | Przeciwciała anty-c5 i sposoby ich stosowania |
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| KR20200095485A (ko) * | 2017-12-04 | 2020-08-10 | 라 파마슈티컬스 인코포레이티드 | 보체 활성의 조절인자 |
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2019
- 2019-08-01 KR KR1020217009233A patent/KR20210038697A/ko not_active IP Right Cessation
- 2019-08-01 CA CA3107618A patent/CA3107618A1/en active Pending
- 2019-08-01 SG SG10202002898RA patent/SG10202002898RA/en unknown
- 2019-08-01 US US17/263,691 patent/US20210301004A1/en active Pending
- 2019-08-01 CN CN201980051238.8A patent/CN112512563A/zh active Pending
- 2019-08-01 DE DE112019003835.4T patent/DE112019003835T5/de active Pending
- 2019-08-01 PL PL19755447.0T patent/PL3829628T3/pl unknown
- 2019-08-01 JP JP2019142108A patent/JP6672516B2/ja active Active
- 2019-08-01 MX MX2021000516A patent/MX2021000516A/es unknown
- 2019-08-01 WO PCT/JP2019/030283 patent/WO2020027279A1/en active Application Filing
- 2019-08-01 HU HUE19755447A patent/HUE067057T2/hu unknown
- 2019-08-01 TW TW109108378A patent/TWI704157B/zh active
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