PL3570882T3 - Nowa stabilna formulacja dla przeciwciał fxia - Google Patents
Nowa stabilna formulacja dla przeciwciał fxiaInfo
- 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
Links
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
Classifications
-
- 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
- A61K39/39591—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
-
- 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
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 (7)
| 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 |
| AU2017383232A1 (en) | 2016-12-23 | 2019-06-27 | Novartis Ag | Factor XI antibodies and methods of use |
| CA3129901A1 (en) | 2019-02-18 | 2020-08-27 | Eli Lilly And Company | Therapeutic antibody formulation |
| JP2023507795A (ja) * | 2019-12-20 | 2023-02-27 | アントス セラピューティクス， インコーポレイテッド | 第ＸＩ／ＸＩａ因子抗体の医薬製剤および投薬レジメン |
| KR20230035079A (ko) | 2020-07-03 | 2023-03-10 | 수조우 알파맵 씨오., 엘티디. | 응고인자 xi(fxi) 결합 단백질 |
| KR20230118167A (ko) * | 2020-12-11 | 2023-08-10 | 베링거 인겔하임 인터내셔날 게엠베하 | 다목적 적용을 위한 제형 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2644275T3 (es) * | 2000-08-11 | 2017-11-28 | Chugai Seiyaku Kabushiki Kaisha | Preparaciones estabilizadas que contienen anticuerpos |
| WO2004055164A2 (en) * | 2002-12-13 | 2004-07-01 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| CN102159204B (zh) * | 2008-09-19 | 2015-04-01 | 辉瑞公司 | 稳定的液体抗体制剂 |
| 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 |
| JP6348900B2 (ja) | 2012-05-10 | 2018-06-27 | バイエル ファーマ アクチエンゲゼルシャフト | 凝固因子ｘｉおよび／またはその活性化形態である因子ｘｉａに結合しうる抗体ならびにその用途 |
| JP6813355B2 (ja) * | 2013-10-25 | 2021-01-13 | バイエル ファーマ アクチエンゲゼルシャフト | 新規な安定製剤 |
-
2018
- 2018-01-16 HR HRP20220011TT patent/HRP20220011T1/hr unknown
- 2018-01-16 PL PL18702623T patent/PL3570882T3/pl unknown
- 2018-01-16 BR BR112019014785-3A patent/BR112019014785A2/pt unknown
- 2018-01-16 US US16/478,029 patent/US20190367636A1/en active Pending
- 2018-01-16 CN CN201880007721.1A patent/CN110234353B/zh active Active
- 2018-01-16 PE PE2019001433A patent/PE20191476A1/es unknown
- 2018-01-16 CA CA3050172A patent/CA3050172A1/en active Pending
- 2018-01-16 KR KR1020197020744A patent/KR20190105588A/ko active IP Right Grant
- 2018-01-16 WO PCT/EP2018/050951 patent/WO2018134184A1/en unknown
- 2018-01-16 SG SG11201906557UA patent/SG11201906557UA/en unknown
- 2018-01-16 JP JP2019538638A patent/JP7072577B2/ja active Active
- 2018-01-16 AU AU2018209118A patent/AU2018209118A1/en active Pending
- 2018-01-16 MX MX2019008544A patent/MX2019008544A/es unknown
- 2018-01-16 EP EP18702623.2A patent/EP3570882B1/en active Active
- 2018-01-16 RS RS20220004A patent/RS62780B1/sr unknown
- 2018-01-16 LT LTEPPCT/EP2018/050951T patent/LT3570882T/lt unknown
- 2018-01-16 PT PT187026232T patent/PT3570882T/pt unknown
- 2018-01-16 HU HUE18702623A patent/HUE056858T2/hu unknown
- 2018-01-16 ES ES18702623T patent/ES2904474T3/es active Active
- 2018-01-16 IL IL267917A patent/IL267917B2/en unknown
- 2018-01-16 SI SI201830483T patent/SI3570882T1/sl unknown
- 2018-01-16 DK DK18702623.2T patent/DK3570882T3/da active
- 2018-01-17 TW TW107101631A patent/TWI753087B/zh active
- 2018-01-19 AR ARP180100130A patent/AR110762A1/es unknown
-
2022
- 2022-01-05 CY CY20221100009T patent/CY1124922T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BR112019014785A2 (pt) | 2020-05-12 |
| AU2018209118A1 (en) | 2019-07-11 |
| WO2018134184A1 (en) | 2018-07-26 |
| CN110234353B (zh) | 2023-07-04 |
| US20190367636A1 (en) | 2019-12-05 |
| HRP20220011T1 (hr) | 2022-04-01 |
| TWI753087B (zh) | 2022-01-21 |
| JP7072577B2 (ja) | 2022-05-20 |
| RU2019125947A3 (pl) | 2021-05-25 |
| HUE056858T2 (hu) | 2022-03-28 |
| LT3570882T (lt) | 2021-12-10 |
| RS62780B1 (sr) | 2022-01-31 |
| CA3050172A1 (en) | 2018-07-26 |
| EP3570882B1 (en) | 2021-11-17 |
| AR110762A1 (es) | 2019-05-02 |
| CN110234353A (zh) | 2019-09-13 |
| TW201831170A (zh) | 2018-09-01 |
| ES2904474T3 (es) | 2022-04-05 |
| RU2019125947A (ru) | 2021-02-19 |
| CY1124922T1 (el) | 2023-01-05 |
| DK3570882T3 (da) | 2022-01-10 |
| JP2020506175A (ja) | 2020-02-27 |
| SG11201906557UA (en) | 2019-08-27 |
| EP3570882A1 (en) | 2019-11-27 |
| PE20191476A1 (es) | 2019-10-16 |
| MX2019008544A (es) | 2019-10-07 |
| IL267917B2 (en) | 2023-10-01 |
| IL267917A (en) | 2019-09-26 |
| PT3570882T (pt) | 2022-01-11 |
| KR20190105588A (ko) | 2019-09-17 |
| SI3570882T1 (sl) | 2022-01-31 |
| IL267917B1 (en) | 2023-06-01 |
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