DK3182993T3 - Lyofiliserede formuleringer til faktor xa-antidot - Google Patents
Lyofiliserede formuleringer til faktor xa-antidot Download PDFInfo
- Publication number
- DK3182993T3 DK3182993T3 DK15834421.8T DK15834421T DK3182993T3 DK 3182993 T3 DK3182993 T3 DK 3182993T3 DK 15834421 T DK15834421 T DK 15834421T DK 3182993 T3 DK3182993 T3 DK 3182993T3
- Authority
- DK
- Denmark
- Prior art keywords
- lyofilized
- antidot
- formulations
- factor
- lyofilized formulations
- Prior art date
Links
- 108010074860 Factor Xa Proteins 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
Classifications
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/26—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
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
- C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
- C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
- C12N9/6424—Serine endopeptidases (3.4.21)
- C12N9/6432—Coagulation factor Xa (3.4.21.6)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21006—Coagulation factor Xa (3.4.21.6)
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Immunology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Hematology (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462039809P | 2014-08-20 | 2014-08-20 | |
| PCT/US2015/046173 WO2016029061A1 (en) | 2014-08-20 | 2015-08-20 | Lyophilized formulations for factor xa antidote |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3182993T3 true DK3182993T3 (da) | 2020-09-21 |
Family
ID=55351266
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15834421.8T DK3182993T3 (da) | 2014-08-20 | 2015-08-20 | Lyofiliserede formuleringer til faktor xa-antidot |
Country Status (14)
| Country | Link |
|---|---|
| US (6) | US20160237420A1 (cg-RX-API-DMAC7.html) |
| EP (2) | EP3182993B1 (cg-RX-API-DMAC7.html) |
| JP (4) | JP6742986B2 (cg-RX-API-DMAC7.html) |
| KR (3) | KR102867491B1 (cg-RX-API-DMAC7.html) |
| CN (2) | CN107073082B (cg-RX-API-DMAC7.html) |
| AU (3) | AU2015305413B2 (cg-RX-API-DMAC7.html) |
| CA (1) | CA2961739C (cg-RX-API-DMAC7.html) |
| DK (1) | DK3182993T3 (cg-RX-API-DMAC7.html) |
| EA (2) | EA202091385A3 (cg-RX-API-DMAC7.html) |
| ES (1) | ES2814157T3 (cg-RX-API-DMAC7.html) |
| IL (2) | IL250413B (cg-RX-API-DMAC7.html) |
| SG (1) | SG11201701247RA (cg-RX-API-DMAC7.html) |
| WO (1) | WO2016029061A1 (cg-RX-API-DMAC7.html) |
| ZA (1) | ZA201701764B (cg-RX-API-DMAC7.html) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010117729A1 (en) * | 2009-03-30 | 2010-10-14 | Portola Pharmaceuticals, Inc. | Antidotes for factor xa inhibitors and methods of using the same |
| CA2961739C (en) | 2014-08-20 | 2024-04-30 | Portola Pharmaceuticals, Inc. | Lyophilized formulations for factor xa antidote |
| US20190046450A1 (en) | 2016-02-24 | 2019-02-14 | Portola Pharmaceuticals, Inc. | Lyophilized formulations for factor xa antidote |
| PE20190661A1 (es) | 2016-06-17 | 2019-05-08 | Portola Pharm Inc | Preparacion de derivados del factor xa |
| EP3624828B1 (en) * | 2017-05-18 | 2024-08-07 | Merck Sharp & Dohme LLC | Pharmaceutical formulation comprising incretin-insulin conjugates |
| US20210196568A1 (en) * | 2018-05-21 | 2021-07-01 | Chugai Seiyaku Kabushiki Kaisha | Lyophilized formulation sealed in glass container |
| CN110760479A (zh) * | 2019-05-17 | 2020-02-07 | 上海交通大学医学院附属瑞金医院 | 靶向血小板表达的凝血因子Xa及其应用 |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE177752T1 (de) | 1992-12-15 | 1999-04-15 | Corvas Int Inc | Neue inhibitoren von faktor xa |
| CN100553678C (zh) | 1999-02-22 | 2009-10-28 | 巴克斯特国际有限公司 | 新的无白蛋白的因子ⅷ制剂 |
| US6586574B1 (en) * | 1999-08-17 | 2003-07-01 | Nn A/S | Stabilization of freeze-dried cake |
| ES2254385T3 (es) | 2000-02-29 | 2006-06-16 | Millennium Pharmaceuticals, Inc. | Benzamidas e inhibidores relacionados del factor xa. |
| US6586584B2 (en) * | 2001-01-29 | 2003-07-01 | Becton, Dickinson And Company | Sequences and methods for detection of Hepatitis C virus |
| CA2512680A1 (en) * | 2003-01-08 | 2004-07-29 | Chiron Corporation | Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants |
| ATE549317T1 (de) | 2005-11-08 | 2012-03-15 | Millennium Pharm Inc | Pharmazeutische salze und polymorphe aus n-(5- chloro-2-pyridinyl)-2-ää4- ä(dimethylamino)iminomethylübenzoylüaminoü-5- methoxy-benzamid, einem faktor-xa-hemmer |
| JO3324B1 (ar) * | 2006-04-21 | 2019-03-13 | Amgen Inc | مركبات علاجية مجففة بالتبريد تتعلق بالعصارة الهضمية |
| DK2915564T3 (da) * | 2007-09-28 | 2021-02-08 | Alexion Pharma Inc | Antidoter mod faktor XA-inhibitorer og fremgangsmåder til anvendelse deraf |
| CN107050437A (zh) | 2008-09-03 | 2017-08-18 | 奥克塔法马股份有限公司 | 重组制备的因子viii的新型保护组合物 |
| JP5709316B2 (ja) | 2008-11-14 | 2015-04-30 | ポートラ ファーマシューティカルズ， インコーポレイテッド | 第Ｘａ因子阻害剤のための解毒剤および血液凝固剤と組み合わせて該解毒剤を使用する方法 |
| WO2010117729A1 (en) | 2009-03-30 | 2010-10-14 | Portola Pharmaceuticals, Inc. | Antidotes for factor xa inhibitors and methods of using the same |
| EP2453910B1 (en) | 2009-07-15 | 2016-08-31 | Portola Pharmaceuticals, Inc. | Unit dose formulation of antidote for factor xa inhibitors for use in preventing bleeding |
| US20120121580A1 (en) * | 2009-07-28 | 2012-05-17 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
| US20130165459A1 (en) * | 2010-01-12 | 2013-06-27 | Norvartis Pharma Ag | Pharmaceutical composition and dosage forms of elinogrel and methods of use thereof |
| KR102049254B1 (ko) * | 2010-04-20 | 2019-11-28 | 옥타파마 아게 | 약학 단백질을 위한 신규한 안정화제 |
| US8987285B2 (en) * | 2010-12-03 | 2015-03-24 | Portola Pharmaceuticals, Inc. | Pharmaceutical compositions, dosage forms and new forms of the compound of formula (I), and methods of use thereof |
| US9683020B2 (en) * | 2011-08-01 | 2017-06-20 | Emory University | VLPS containing ligands and methods related thereto |
| AU2012315516B2 (en) * | 2011-09-30 | 2017-05-04 | The Children's Hospital Of Philadelphia | Compositions and methods for modulating hemostasis |
| GB201310946D0 (en) * | 2013-06-19 | 2013-07-31 | Cambridge Entpr Ltd | Antidote |
| CA2961739C (en) * | 2014-08-20 | 2024-04-30 | Portola Pharmaceuticals, Inc. | Lyophilized formulations for factor xa antidote |
-
2015
- 2015-08-20 CA CA2961739A patent/CA2961739C/en active Active
- 2015-08-20 AU AU2015305413A patent/AU2015305413B2/en active Active
- 2015-08-20 CN CN201580048166.3A patent/CN107073082B/zh active Active
- 2015-08-20 SG SG11201701247RA patent/SG11201701247RA/en unknown
- 2015-08-20 EP EP15834421.8A patent/EP3182993B1/en active Active
- 2015-08-20 KR KR1020227045749A patent/KR102867491B1/ko active Active
- 2015-08-20 EP EP20170763.5A patent/EP3750556A1/en active Pending
- 2015-08-20 EA EA202091385A patent/EA202091385A3/ru unknown
- 2015-08-20 DK DK15834421.8T patent/DK3182993T3/da active
- 2015-08-20 KR KR1020177007503A patent/KR102482517B1/ko active Active
- 2015-08-20 CN CN202110363277.0A patent/CN113171447B/zh active Active
- 2015-08-20 KR KR1020257032508A patent/KR20250150675A/ko active Pending
- 2015-08-20 JP JP2017509739A patent/JP6742986B2/ja active Active
- 2015-08-20 WO PCT/US2015/046173 patent/WO2016029061A1/en not_active Ceased
- 2015-08-20 EA EA201790415A patent/EA036091B1/ru unknown
- 2015-08-20 ES ES15834421T patent/ES2814157T3/es active Active
-
2016
- 2016-04-22 US US15/136,810 patent/US20160237420A1/en not_active Abandoned
-
2017
- 2017-02-02 IL IL250413A patent/IL250413B/en active IP Right Grant
- 2017-03-10 ZA ZA2017/01764A patent/ZA201701764B/en unknown
- 2017-11-21 US US15/820,265 patent/US20180320160A1/en not_active Abandoned
-
2019
- 2019-09-12 JP JP2019165981A patent/JP2019206595A/ja not_active Withdrawn
-
2020
- 2020-06-08 US US16/895,448 patent/US11028382B2/en active Active
- 2020-06-08 US US16/895,443 patent/US20200299667A1/en not_active Abandoned
- 2020-08-26 IL IL276960A patent/IL276960B/en unknown
- 2020-12-16 AU AU2020289768A patent/AU2020289768B2/en active Active
-
2021
- 2021-05-28 US US17/334,427 patent/US20210284986A1/en not_active Abandoned
- 2021-10-22 JP JP2021172975A patent/JP7416549B2/ja active Active
-
2023
- 2023-09-11 JP JP2023146769A patent/JP2023158199A/ja active Pending
-
2024
- 2024-09-13 AU AU2024219698A patent/AU2024219698A1/en active Pending
- 2024-11-05 US US18/937,646 patent/US20250163399A1/en active Pending
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