ME02865B - C1-inh kompozicije za upotrebu u prevenciji i liječenju naslednog angioedema (hae) - Google Patents
C1-inh kompozicije za upotrebu u prevenciji i liječenju naslednog angioedema (hae)Info
- Publication number
- ME02865B ME02865B MEP-2017-182A MEP2017182A ME02865B ME 02865 B ME02865 B ME 02865B ME P2017182 A MEP2017182 A ME P2017182A ME 02865 B ME02865 B ME 02865B
- Authority
- ME
- Montenegro
- Prior art keywords
- composition
- esterase inhibitor
- use according
- units
- hae
- Prior art date
Links
Classifications
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- 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
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/16—Blood plasma; Blood serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
-
- 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
- A61K38/55—Protease inhibitors
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
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- 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
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- 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
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- 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
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- 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
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- 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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
-
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/81—Protease inhibitors
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Marine Sciences & Fisheries (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Cell Biology (AREA)
- Hematology (AREA)
- Developmental Biology & Embryology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Virology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Biotechnology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Claims (13)
1.Kompozicija koja sadrži najmanje jedan inhibitor C1 esteraze pri čemu je najmanje jedan inhibitor C1 esteraze prisutan na 400U/ml ili više za upotrebu u lečenju, inhibiciji, ili sprečavanju naslednog angioedema (HAE) i pri čemu se pomenuta kompozicija daje subkutano.
2.Kompozicija za upotrebu prema zahtevu 1, pri čemu je najmanje jedan inhibitor C1 esteraze inhibitor prisutan na do 500 U/ml.
3.Kompozicija za upotrebu prema zahtevu 1 ili zahtevu 2, pri čemu se najmanje jedan inhibitor C1 esteraze daje u dozi koja ima opseg od 500 jedinica do oko 5000 jedinica, 1000 jedinica do 3500 jedinica, ili 1500 jedinica do 2500 jedinica.
4.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu se najmanje jedan inhibitor C1 esteraze daje dnevno, svakog drugog dana, svaka 3 dana, jednom nedeljno, dva puta nedeljno ili tri puta nedeljno.
5.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu se subjektu daje visoka početna doza najmanje jednog inhibitora C1 esteraze, nakon čega slede manje doze za održavanje, gde je po potrebi visoka početna doza najmanje 1,5, 2, 3, 4, ili 5 puta naknadnih doza, i/ili se visoka početna doza daje intravenozno i najmanje jedan inhibitor C1 esteraze se nakon toga daje subkutano.
6.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu davanje najmanje jednog inhibitora C1 esteraze dovodi do povećanih nivoa inhibitora C1 esteraze u krvi subjekta, pri čemu su nivoi inhibitora C1 esteraze u krvi povećani do najmanje 0,3 U/mL, 0,4 U/mL, ili do 1 U/mL.
7.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu se nivoi inhibitora C1 esteraze u krvi održavaju na ili iznad 0,4 U/mL za najmanje 50%, najmanje 75%, najmanje 90%, najmanje 95% vremena.
8.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu: (i) nasledni angioedem je Tip I ili Tip II HAE, (ii) davanje najmanje jednog inhibitora C1 esteraze dovodi do profilaktičkog lečenja HAE, (iii) lečenje HAE dovodi najmanje do smanjenja u ozbiljnosti i/ili broju HAE napada, ili (iv) davanje najmanje jednog inhibitora C1 esteraze dovodi do lečenja HAE napada.
9.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu je najmanje jedan inhibitor C1 esteraze izolovan ili prečišćen iz humane plazme ili je dobijen pomoću tehnika rekombinacije, i/ili pri čemu inhibior C1 esteraze ima sekvencu amino kiselina 90%, 95%, 98%, 99% ili 100% identičnu sa humanom sekvencom amino kiselina inhibitora C1 esteraze na slici 1.
10.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu kompozicija sadrži pufer, koji sadrži citrat ili natrijum citrat, po potrebi 5mM do 50 mM natrijum citrat, 10 mM do 30 mM natrijum citrat, ili 20 mM natrijum citrat.
11.Kompozicija za upotrebu prema bilo kom od prethodnih zahteva 1-9, koja sadrži pufer, pri čemu pufer ne sadrži citrat ili limunsku kiselinu.
12.Kompozicija za upotrebu prema bilo kom prethodnom zahtevu, pri čemu kompozicija: (i) sadrži najmanje jednu amino kiselinu ili njenu so; i/ili (ii) ima pH između 6,5 i 8,0.
13. Kompozicija za upotrebu prema bilo kom prethodnom zahtevu pri čemu se kompozicija dobija iz liofilizovanog oblika rekonstitucijom u puferu pre davanja.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361791399P | 2013-03-15 | 2013-03-15 | |
| EP14762343.3A EP2968434B1 (en) | 2013-03-15 | 2014-03-17 | C1-inh compositions for use in the prevention and treatment of hereditary angioedema (hae). |
| PCT/US2014/030309 WO2014145519A2 (en) | 2013-03-15 | 2014-03-17 | C1-inh compositions and methods for the prevention and treatment of disorders associated with c1 esterase inhibitor deficency |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02865B true ME02865B (me) | 2018-04-20 |
Family
ID=51538486
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2019-45A ME03326B (me) | 2013-03-15 | 2014-03-17 | C1-inh kompozicije i postupci za prevenciju i liječenje poremećaja koji su povezani sa deficijencijom inhibitora c1 esteraze |
| MEP-2017-182A ME02865B (me) | 2013-03-15 | 2014-03-17 | C1-inh kompozicije za upotrebu u prevenciji i liječenju naslednog angioedema (hae) |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2019-45A ME03326B (me) | 2013-03-15 | 2014-03-17 | C1-inh kompozicije i postupci za prevenciju i liječenje poremećaja koji su povezani sa deficijencijom inhibitora c1 esteraze |
Country Status (30)
| Country | Link |
|---|---|
| US (9) | US9616111B2 (me) |
| EP (3) | EP3290046B1 (me) |
| JP (9) | JP6184581B2 (me) |
| KR (4) | KR20150135242A (me) |
| CN (2) | CN111529708A (me) |
| AU (3) | AU2014232912A1 (me) |
| BR (1) | BR112015023207A8 (me) |
| CA (2) | CA3054718A1 (me) |
| CY (2) | CY1119419T1 (me) |
| DE (1) | DE202014011208U1 (me) |
| DK (2) | DK3290046T3 (me) |
| EA (1) | EA201591278A1 (me) |
| ES (2) | ES2639833T3 (me) |
| GB (1) | GB2530921B (me) |
| HK (1) | HK1250912B (me) |
| HR (2) | HRP20171269T1 (me) |
| HU (2) | HUE041837T2 (me) |
| IL (2) | IL241549B (me) |
| LT (2) | LT2968434T (me) |
| ME (2) | ME03326B (me) |
| MX (3) | MX389449B (me) |
| PL (2) | PL3290046T3 (me) |
| PT (2) | PT2968434T (me) |
| RS (2) | RS58351B1 (me) |
| SG (2) | SG10201707598QA (me) |
| SI (2) | SI2968434T1 (me) |
| SM (2) | SMT201900141T1 (me) |
| TR (1) | TR201900319T4 (me) |
| WO (1) | WO2014145519A2 (me) |
| ZA (3) | ZA201507604B (me) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ME03326B (me) | 2013-03-15 | 2019-10-20 | Shire Viropharma Inc | C1-inh kompozicije i postupci za prevenciju i liječenje poremećaja koji su povezani sa deficijencijom inhibitora c1 esteraze |
| ES2708655T3 (es) | 2013-11-22 | 2019-04-10 | Shire Viropharma Inc | Métodos para tratar el rechazo mediado por anticuerpos en pacientes con trasplante de órganos con el inhibidor de la c1-esterasa |
| JP6516855B2 (ja) * | 2015-02-20 | 2019-05-22 | ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー | Ｃ１エステラーゼ阻害剤の医薬製剤 |
| CN108025047B (zh) * | 2015-05-28 | 2021-11-19 | 康奈尔大学 | 腺相关病毒介导的c1ei递送作为用于血管性水肿的疗法 |
| WO2017087882A1 (en) * | 2015-11-19 | 2017-05-26 | Shire Human Genetic Therapies, Inc. | Recombinant human c1 esterase inhibitor and uses thereof |
| US20190175683A1 (en) * | 2016-08-05 | 2019-06-13 | Csl Behring Gmbh | Pharmaceutical formulations of c1 esterase inhibitor |
| JP2019534240A (ja) * | 2016-08-23 | 2019-11-28 | ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー | Ｃ１エステラーゼ阻害剤欠乏に関連する遺伝性血管浮腫の急性発作を予防する方法 |
| BR112019023737A2 (pt) * | 2017-05-16 | 2020-05-26 | Octapharma Ag | Preparação de inibidor de c1-esterase (c1-inh), kit que consiste em um primeiro receptáculo contendo a preparação de c1-inh, kit que consiste em uma seringa pré-cheia com a preparação de c1-inh, kit que consiste em um dispositivo adequado para aplicação subcutânea, tal como um injetor no corpo e uso de histidina para aumentar a biodisponibilidade de c1-inh administrado por via subcutânea |
| WO2019166572A1 (en) | 2018-02-28 | 2019-09-06 | Pharming Intellectual Property B.V. | Pharmaceutical system for transdermal administration of a c1 -esterase inhibitor |
| US20200390872A1 (en) | 2018-02-28 | 2020-12-17 | Pharming Intellectual Property B.V. | Treatment and prevention of pre-eclampsia |
| WO2019245038A1 (ja) | 2018-06-22 | 2019-12-26 | 株式会社Ｊｕｎｔｅｎ Ｂｉｏ | 複合状態を有する細胞混合物を用いた、免疫寛容を誘導する抗体、及び誘導されたリンパ球、また誘導されたリンパ球を用いる細胞治療剤及び治療法 |
| TWI854983B (zh) | 2018-06-22 | 2024-09-11 | 日商順天生化股份有限公司 | 誘導免疫耐受之抗體、被誘導之淋巴球、及使用被誘導之淋巴球之細胞治療劑治療方法 |
| TWI832868B (zh) | 2018-06-22 | 2024-02-21 | 日商順天生化股份有限公司 | 用於誘發感染性免疫耐受之組合物 |
| JP7718272B2 (ja) * | 2019-12-16 | 2025-08-05 | ニプロ株式会社 | 凝集防止剤ならびにそれを用いた医薬組成物および医療用デバイス |
| EP3895726A1 (en) | 2020-04-17 | 2021-10-20 | Pharming Intellectual Property BV | Using c1 esterase inhibitor to treat viral infection-related acute respiratory distress |
| CN117120076A (zh) * | 2021-01-27 | 2023-11-24 | 斯帕克治疗公司 | 用于治疗遗传性血管性水肿的组合物和方法 |
| EP4366761A1 (en) | 2021-07-09 | 2024-05-15 | Pharming Intellectual Property B.V. | Using c1 esterase inhibitor to treat viral infection-related symptoms |
| KR20230046146A (ko) | 2021-09-29 | 2023-04-05 | 주식회사 엘지에너지솔루션 | 배터리 제어 시스템 및 방법 |
| WO2025090843A1 (en) * | 2023-10-27 | 2025-05-01 | Kansas State University Research Foundation | Small-molecule inhibitors of c1s protease and classical complement pathway |
| CN119823254B (zh) * | 2025-03-14 | 2025-06-03 | 深圳市卫光生物制品股份有限公司 | 一种c1酯酶抑制剂重组变体及其制备方法和应用 |
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