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
Links
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 102000015081 Blood Coagulation Factors Human genes 0.000 abstract 1
- 108010039209 Blood Coagulation Factors Proteins 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000003114 blood coagulation factor Substances 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000012669 liquid formulation Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 238000011321 prophylaxis Methods 0.000 abstract 1
- 238000002560 therapeutic procedure Methods 0.000 abstract 1
- 230000009424 thromboembolic effect Effects 0.000 abstract 1
- 230000001732 thrombotic effect Effects 0.000 abstract 1
Classifications
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- 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
- C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate 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
-
- 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
- A61P7/02—Antithrombotic 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.
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)
| 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)
| 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 |
-
2018
- 2018-01-16 PE PE2019001433A patent/PE20191476A1/es unknown
- 2018-01-16 AU AU2018209118A patent/AU2018209118A1/en not_active Abandoned
- 2018-01-16 MX MX2019008544A patent/MX2019008544A/es unknown
- 2018-01-16 DK DK18702623.2T patent/DK3570882T3/da active
- 2018-01-16 IL IL267917A patent/IL267917B2/en unknown
- 2018-01-16 CA CA3050172A patent/CA3050172A1/en active Pending
- 2018-01-16 SG SG11201906557UA patent/SG11201906557UA/en unknown
- 2018-01-16 SI SI201830483T patent/SI3570882T1/sl unknown
- 2018-01-16 ES ES18702623T patent/ES2904474T3/es active Active
- 2018-01-16 WO PCT/EP2018/050951 patent/WO2018134184A1/en not_active Ceased
- 2018-01-16 US US16/478,029 patent/US20190367636A1/en not_active Abandoned
- 2018-01-16 RS RS20220004A patent/RS62780B1/sr unknown
- 2018-01-16 BR BR112019014785-3A patent/BR112019014785A2/pt not_active Application Discontinuation
- 2018-01-16 PL PL18702623T patent/PL3570882T3/pl unknown
- 2018-01-16 KR KR1020197020744A patent/KR20190105588A/ko active Pending
- 2018-01-16 LT LTEPPCT/EP2018/050951T patent/LT3570882T/lt unknown
- 2018-01-16 EP EP18702623.2A patent/EP3570882B1/en active Active
- 2018-01-16 JP JP2019538638A patent/JP7072577B2/ja not_active Expired - Fee Related
- 2018-01-16 HU HUE18702623A patent/HUE056858T2/hu unknown
- 2018-01-16 CN CN201880007721.1A patent/CN110234353B/zh not_active Expired - Fee Related
- 2018-01-16 PT PT187026232T patent/PT3570882T/pt unknown
- 2018-01-16 HR HRP20220011TT patent/HRP20220011T1/hr unknown
- 2018-01-17 TW TW107101631A patent/TWI753087B/zh not_active IP Right Cessation
- 2018-01-19 AR ARP180100130A patent/AR110762A1/es not_active Application Discontinuation
-
2022
- 2022-01-05 CY CY20221100009T patent/CY1124922T1/el unknown
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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