PL3570882T3 - Nowa stabilna formulacja dla przeciwciał fxia - Google Patents

Nowa stabilna formulacja dla przeciwciał fxia

Info

Publication number
PL3570882T3
PL3570882T3 PL18702623T PL18702623T PL3570882T3 PL 3570882 T3 PL3570882 T3 PL 3570882T3 PL 18702623 T PL18702623 T PL 18702623T PL 18702623 T PL18702623 T PL 18702623T PL 3570882 T3 PL3570882 T3 PL 3570882T3
Authority
PL
Poland
Prior art keywords
stable formulation
novel stable
fxia antibodies
fxia
antibodies
Prior art date
Application number
PL18702623T
Other languages
English (en)
Inventor
Carsten Olbrich
Thomas Trill
Marieke Veurink
Original Assignee
Bayer Pharma Aktiengesellschaft
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
Application filed by Bayer Pharma Aktiengesellschaft filed Critical Bayer Pharma Aktiengesellschaft
Publication of PL3570882T3 publication Critical patent/PL3570882T3/pl

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • 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
    • 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
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Peptides Or Proteins (AREA)
PL18702623T 2017-01-19 2018-01-16 Nowa stabilna formulacja dla przeciwciał fxia PL3570882T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17152108 2017-01-19
PCT/EP2018/050951 WO2018134184A1 (en) 2017-01-19 2018-01-16 Novel stable formulation for fxia antibodies
EP18702623.2A EP3570882B1 (en) 2017-01-19 2018-01-16 Novel stable formulation for fxia antibodies

Publications (1)

Publication Number Publication Date
PL3570882T3 true PL3570882T3 (pl) 2022-02-07

Family

ID=57914707

Family Applications (1)

Application Number Title Priority Date Filing Date
PL18702623T PL3570882T3 (pl) 2017-01-19 2018-01-16 Nowa stabilna formulacja dla przeciwciał fxia

Country Status (25)

Country Link
US (1) US20190367636A1 (pl)
EP (1) EP3570882B1 (pl)
JP (1) JP7072577B2 (pl)
KR (1) KR20190105588A (pl)
CN (1) CN110234353B (pl)
AR (1) AR110762A1 (pl)
AU (1) AU2018209118A1 (pl)
BR (1) BR112019014785A2 (pl)
CA (1) CA3050172A1 (pl)
CY (1) CY1124922T1 (pl)
DK (1) DK3570882T3 (pl)
ES (1) ES2904474T3 (pl)
HR (1) HRP20220011T1 (pl)
HU (1) HUE056858T2 (pl)
IL (1) IL267917B2 (pl)
LT (1) LT3570882T (pl)
MX (1) MX2019008544A (pl)
PE (1) PE20191476A1 (pl)
PL (1) PL3570882T3 (pl)
PT (1) PT3570882T (pl)
RS (1) RS62780B1 (pl)
SG (1) SG11201906557UA (pl)
SI (1) SI3570882T1 (pl)
TW (1) TWI753087B (pl)
WO (1) WO2018134184A1 (pl)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20200312A1 (ar) 2015-06-26 2017-06-16 Novartis Ag الأجسام المضادة للعامل xi وطرق الاستخدام
TW201802121A (zh) 2016-05-25 2018-01-16 諾華公司 抗因子XI/XIa抗體之逆轉結合劑及其用途
US11168147B2 (en) 2016-12-23 2021-11-09 Novartis Ag Factor XI antibodies and methods of use
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
IL293367A (en) * 2019-12-20 2022-07-01 Anthos Therapeutics Inc Pharmaceutical formulations and dosage regimens for antibodies to factor xi/xia
AU2021247501A1 (en) * 2020-04-03 2022-10-27 Bayer Aktiengesellschaft Pharmaceutical formulations polyethylene glycol-based prodrugs of Adrenomedullin and use
WO2022002233A1 (zh) 2020-07-03 2022-01-06 苏州康宁杰瑞生物科技有限公司 凝血因子xi(fxi)结合蛋白
US20240383968A1 (en) * 2020-12-11 2024-11-21 Boehringer Ingelheim International Gmbh Formulation for multi-purpose application
WO2023131213A1 (zh) * 2022-01-05 2023-07-13 上海迈晋生物医药科技有限公司 一种包含抗FXI/FXIa抗体的药物组合物及其用途

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8632778B2 (en) * 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
AU2003293543A1 (en) * 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
TR201802935T4 (tr) * 2008-09-19 2018-03-21 Pfizer Stabil sıvı antikor formülasyonu.
BRPI0921845A2 (pt) * 2008-11-12 2019-09-17 Medimmune Llc formulação aquosa estéril estável, forma de dosagem unitária farmacêutica, seringa pré-carregada, e, métodos para tratar uma doença ou distúrbio, para tratar ou prevenir rejeição, para esgotar células t que expressam icos em um paciente humano, e para interromper arquitetura central germinal em um órgão linfóide secundário de um primata
EP2847228B1 (en) * 2012-05-10 2018-07-25 Bayer Pharma Aktiengesellschaft Antibodies capable of binding to the coagulation factor xi and/or its activated form factor xia and uses thereof
US20160250349A1 (en) * 2013-10-25 2016-09-01 Bayer Pharma Aktiengesellschaft A novel stable formulation

Also Published As

Publication number Publication date
RU2019125947A (ru) 2021-02-19
IL267917B2 (en) 2023-10-01
EP3570882B1 (en) 2021-11-17
WO2018134184A1 (en) 2018-07-26
EP3570882A1 (en) 2019-11-27
CA3050172A1 (en) 2018-07-26
AR110762A1 (es) 2019-05-02
PE20191476A1 (es) 2019-10-16
PT3570882T (pt) 2022-01-11
KR20190105588A (ko) 2019-09-17
CN110234353B (zh) 2023-07-04
JP2020506175A (ja) 2020-02-27
HRP20220011T1 (hr) 2022-04-01
CN110234353A (zh) 2019-09-13
RS62780B1 (sr) 2022-01-31
RU2019125947A3 (pl) 2021-05-25
TW201831170A (zh) 2018-09-01
IL267917A (en) 2019-09-26
MX2019008544A (es) 2019-10-07
DK3570882T3 (da) 2022-01-10
SI3570882T1 (sl) 2022-01-31
JP7072577B2 (ja) 2022-05-20
IL267917B1 (en) 2023-06-01
US20190367636A1 (en) 2019-12-05
SG11201906557UA (en) 2019-08-27
ES2904474T3 (es) 2022-04-05
BR112019014785A2 (pt) 2020-05-12
LT3570882T (lt) 2021-12-10
HUE056858T2 (hu) 2022-03-28
TWI753087B (zh) 2022-01-21
AU2018209118A1 (en) 2019-07-11
CY1124922T1 (el) 2023-01-05

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