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MX2019008544A - Nueva formulacion estable para anticuerpos anti-fxia. - Google Patents

Nueva formulacion estable para anticuerpos anti-fxia.

Info

Publication number
MX2019008544A
MX2019008544A MX2019008544A MX2019008544A MX2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A
Authority
MX
Mexico
Prior art keywords
stable formulation
novel stable
fxia antibodies
refers
fxia
Prior art date
Application number
MX2019008544A
Other languages
English (en)
Inventor
Olbrich Carsten
Trill Thomas
VEURINK Marieke
Original Assignee
Bayer Pharma AG
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 AG filed Critical Bayer Pharma AG
Publication of MX2019008544A publication Critical patent/MX2019008544A/es

Links

Classifications

    • 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
    • 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
    • C07K16/36Immunoglobulins [IGs], 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
    • A61K39/39533Antibodies; 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)

Abstract

Nuevas formulaciones farmacéuticas líquidas que comprenden un anticuerpo humano contra el factor de coagulación FXIa como ingrediente activo. La invención también se refiere a liofilizados de la formulación líquida especificada y también a su uso en la terapia y la profilaxis de trastornos trombóticos o tromboembólicos.
MX2019008544A 2017-01-19 2018-01-16 Nueva formulacion estable para anticuerpos anti-fxia. MX2019008544A (es)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
MX2019008544A true MX2019008544A (es) 2019-10-07

Family

ID=57914707

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019008544A MX2019008544A (es) 2017-01-19 2018-01-16 Nueva formulacion estable para anticuerpos anti-fxia.

Country Status (25)

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

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
KR102616666B1 (ko) 2016-12-23 2023-12-27 노파르티스 아게 인자 xi 항체 및 사용 방법
PH12021551916A1 (en) 2019-02-18 2022-05-23 Lilly Co Eli Therapeutic antibody formulation.
EP4076511A4 (en) * 2019-12-20 2024-02-14 Anthos Therapeutics, Inc. PHARMACEUTICAL FORMULATIONS AND DOSAGE SCHEDULES FOR FACTOR XI/XIA ANTIBODIES
PH12022552652A1 (en) * 2020-04-03 2024-02-05 Bayer Ag Pharmaceutical formulations polyethylene glycol-based prodrugs of adrenomedullin and use
AU2021302199A1 (en) 2020-07-03 2023-02-23 Suzhou Alphamab Co., Ltd. Coagulation factor XI (FXI) binding protein
US20240383968A1 (en) * 2020-12-11 2024-11-21 Boehringer Ingelheim International Gmbh Formulation for multi-purpose application
EP4461749A4 (en) * 2022-01-05 2025-03-26 Shanghai Mabgen Biotech Ltd. Pharmaceutical composition containing anti-FXI/FXIA antibodies and use thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2477996T3 (es) * 2000-08-11 2014-07-18 Chugai Seiyaku Kabushiki Kaisha Preparaciones estabilizadas que contienen un anticuerpo
US20040191243A1 (en) 2002-12-13 2004-09-30 Bei Chen System and method for stabilizing antibodies with histidine
SI2331090T1 (en) * 2008-09-19 2018-04-30 Pfizer Inc. Stable liquid antibody formulation
CA2743469C (en) * 2008-11-12 2019-01-15 Medimmune, Llc Antibody formulation
BR112014027952B1 (pt) 2012-05-10 2022-06-21 Bayer Pharma Aktiengesellschaft Anticorpos monoclonais humanos capazes de se ligarem ao fator de coagulação xi, seu uso, composição farmacêutica e medicamento os compreendendo, ácido nucleico que o codifica, bem como vetor
WO2015059147A1 (en) * 2013-10-25 2015-04-30 Bayer Pharma Aktiengesellschaft A novel stable formulation

Also Published As

Publication number Publication date
PT3570882T (pt) 2022-01-11
CN110234353A (zh) 2019-09-13
SG11201906557UA (en) 2019-08-27
WO2018134184A1 (en) 2018-07-26
AR110762A1 (es) 2019-05-02
JP7072577B2 (ja) 2022-05-20
TW201831170A (zh) 2018-09-01
EP3570882A1 (en) 2019-11-27
PE20191476A1 (es) 2019-10-16
AU2018209118A1 (en) 2019-07-11
LT3570882T (lt) 2021-12-10
PL3570882T3 (pl) 2022-02-07
HUE056858T2 (hu) 2022-03-28
IL267917B1 (en) 2023-06-01
TWI753087B (zh) 2022-01-21
US20190367636A1 (en) 2019-12-05
BR112019014785A2 (pt) 2020-05-12
CN110234353B (zh) 2023-07-04
RU2019125947A (ru) 2021-02-19
ES2904474T3 (es) 2022-04-05
KR20190105588A (ko) 2019-09-17
JP2020506175A (ja) 2020-02-27
CA3050172A1 (en) 2018-07-26
RU2019125947A3 (es) 2021-05-25
IL267917A (en) 2019-09-26
RS62780B1 (sr) 2022-01-31
CY1124922T1 (el) 2023-01-05
EP3570882B1 (en) 2021-11-17
IL267917B2 (en) 2023-10-01
SI3570882T1 (sl) 2022-01-31
DK3570882T3 (da) 2022-01-10
HRP20220011T1 (hr) 2022-04-01

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