HRP20170056T2 - Terapija male učestalosti glatiramer acetatom - Google Patents
Terapija male učestalosti glatiramer acetatom Download PDFInfo
- Publication number
- HRP20170056T2 HRP20170056T2 HRP20170056TT HRP20170056T HRP20170056T2 HR P20170056 T2 HRP20170056 T2 HR P20170056T2 HR P20170056T T HRP20170056T T HR P20170056TT HR P20170056 T HRP20170056 T HR P20170056T HR P20170056 T2 HRP20170056 T2 HR P20170056T2
- Authority
- HR
- Croatia
- Prior art keywords
- glatiramer acetate
- injection
- treatment
- multiple sclerosis
- reaction
- Prior art date
Links
- 108010072051 Glatiramer Acetate Proteins 0.000 title claims 9
- FHEAIOHRHQGZPC-KIWGSFCNSA-N acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound CC(O)=O.C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 FHEAIOHRHQGZPC-KIWGSFCNSA-N 0.000 title claims 9
- 229960003776 glatiramer acetate Drugs 0.000 title claims 9
- 238000002560 therapeutic procedure Methods 0.000 title 1
- 238000002347 injection Methods 0.000 claims 4
- 239000007924 injection Substances 0.000 claims 4
- 201000006417 multiple sclerosis Diseases 0.000 claims 4
- 238000010254 subcutaneous injection Methods 0.000 claims 4
- 239000007929 subcutaneous injection Substances 0.000 claims 4
- 239000003814 drug Substances 0.000 claims 3
- 229940079593 drug Drugs 0.000 claims 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/07—Tetrapeptides
-
- 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
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Gastroenterology & Hepatology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Neurosurgery (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Biochemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Magnetic Resonance Imaging Apparatus (AREA)
Claims (4)
1. Glatiramer acetat za primjenu prema protokolu davanja od tri supkutane injekcije u dozi od 40mg glatiramer acetata svakih sedam dana uz barem jedan dan između svake supkutane injekcije za uporabu u liječenju pacijenta koji pati od relapsnog oblika multiple skleroze ili koji je iskusio prvu kliničku epizodu i pod visokim je rizikom od razvoja klinički konačne multiple skleroze, i gdje farmaceutski sastav nadalje sadrži manitol.
2. Lijek koji sadrži glatiramer acetat za primjenu u liječenju pacijenta koji pati od relapsnog oblika multiple skleroze ili koji je iskusio prvu kliničku epizodu i pod visokim je rizikom od razvoja klinički konačne multiple skleroze, naznačen time, da lijek treba davati prema protokolu davanja od tri supkutane injekcije u dozi od 40mg glatiramer acetata svakih sedam dana, uz barem jedan dan između svake supkutane injekcije i kod čega farmaceutski sastav nadalje sadrži manitol.
3. Glatiramer acetat za uporabu prema patentnom zahtjevu 1, naznačen time, da se tolerancija kod pacijenta na liječenje glatiramer acetatom povećava smanjivanjem učestalosti reakcije neposredno nakon injekcije ili reakcije na mjestu uboda.
4. Lijek koji sadrži glatiramer acetat za uporabu prema patentnom zahtjevu 2, naznačen time, da se tolerancija kod pacijenta na liječenje glatiramer acetatom povećava smanjivanjem učestalosti reakcije neposredno nakon injekcije ili reakcije na mjestu uboda.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US27468709P | 2009-08-20 | 2009-08-20 | |
| US33761210P | 2010-02-11 | 2010-02-11 | |
| EP15171065.4A EP2949335B1 (en) | 2009-08-20 | 2010-08-19 | Low frequency glatiramer acetate therapy |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20170056T1 HRP20170056T1 (hr) | 2017-03-24 |
| HRP20170056T2 true HRP20170056T2 (hr) | 2017-12-15 |
Family
ID=43605835
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20130677AT HRP20130677T1 (en) | 2009-08-20 | 2013-07-17 | Low frequency glatiramer acetate therapy |
| HRP20170056TT HRP20170056T2 (hr) | 2009-08-20 | 2017-01-13 | Terapija male učestalosti glatiramer acetatom |
| HRP20181253TT HRP20181253T1 (hr) | 2009-08-20 | 2018-08-06 | Terapija male učestalosti glatiramer acetatom |
| HRP20181254TT HRP20181254T1 (hr) | 2009-08-20 | 2018-08-06 | Režim doziranja za multiplu sklerozu |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20130677AT HRP20130677T1 (en) | 2009-08-20 | 2013-07-17 | Low frequency glatiramer acetate therapy |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20181253TT HRP20181253T1 (hr) | 2009-08-20 | 2018-08-06 | Terapija male učestalosti glatiramer acetatom |
| HRP20181254TT HRP20181254T1 (hr) | 2009-08-20 | 2018-08-06 | Režim doziranja za multiplu sklerozu |
Country Status (34)
| Country | Link |
|---|---|
| US (15) | US8399413B2 (hr) |
| EP (5) | EP2630962B1 (hr) |
| JP (3) | JP6038653B2 (hr) |
| KR (4) | KR20140061559A (hr) |
| CN (3) | CN107050423A (hr) |
| AR (2) | AR077896A1 (hr) |
| AT (1) | AT15421U1 (hr) |
| AU (1) | AU2010284666B2 (hr) |
| BR (1) | BR112012003730A2 (hr) |
| CA (2) | CA2760802C (hr) |
| CY (2) | CY1114537T1 (hr) |
| CZ (2) | CZ30474U1 (hr) |
| DE (1) | DE202010018377U1 (hr) |
| DK (5) | DK2949335T3 (hr) |
| EA (3) | EA032283B1 (hr) |
| ES (4) | ES2688873T3 (hr) |
| HK (4) | HK1165959A1 (hr) |
| HR (4) | HRP20130677T1 (hr) |
| HU (2) | HUE039335T2 (hr) |
| IL (3) | IL218106A0 (hr) |
| LT (3) | LT3199172T (hr) |
| ME (2) | ME01536B (hr) |
| MX (1) | MX2012002082A (hr) |
| NZ (1) | NZ598661A (hr) |
| PL (4) | PL2949335T3 (hr) |
| PT (4) | PT2630962T (hr) |
| RS (2) | RS55607B1 (hr) |
| SG (2) | SG10201405806SA (hr) |
| SI (4) | SI2630962T1 (hr) |
| SK (1) | SK501352015U1 (hr) |
| SM (1) | SMT201700057B (hr) |
| TW (3) | TWI643614B (hr) |
| UA (1) | UA103699C2 (hr) |
| WO (1) | WO2011022063A1 (hr) |
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| ES2527760T3 (es) * | 1998-07-23 | 2015-01-29 | Yeda Research And Development Co., Ltd. | Tratamiento de enfermedad de Crohn con copolímero 1 y polipéptidos |
| US8077333B2 (en) * | 2002-09-09 | 2011-12-13 | Canon Kabushiki Kaisha | Printing control apparatus and printing control method |
| LT3199172T (lt) * | 2009-08-20 | 2018-10-25 | Yeda Research And Development Co., Ltd. | Dozavimo režimas, skirtas išsėtinei sklerozei |
| USRE49251E1 (en) | 2010-01-04 | 2022-10-18 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
| US8759302B2 (en) * | 2010-03-16 | 2014-06-24 | Teva Pharmaceutical Industries, Ltd. | Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis |
| PT2627669T (pt) | 2010-10-11 | 2016-11-24 | Teva Pharma | Biomarcadores de citocina como biomarcadores preditivos de resposta clínica para acetato de glatirâmero |
| WO2013055683A1 (en) | 2011-10-10 | 2013-04-18 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| TW201420111A (zh) | 2012-10-10 | 2014-06-01 | Teva Pharma | 對格拉默醋酸鹽（ｇｌａｔｉｒａｍｅｒ ａｃｅｔａｔｅ）之臨床反應具預測性之生物標記 |
| SG11201505210RA (en) * | 2013-01-04 | 2015-07-30 | Teva Pharma | Characterizing a glatiramer acetate related drug product |
| UY35790A (es) | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
| CN103641897B (zh) * | 2013-11-27 | 2017-01-04 | 深圳翰宇药业股份有限公司 | 一种合成醋酸格拉替雷的方法 |
| US9763992B2 (en) | 2014-02-13 | 2017-09-19 | Father Flanagan's Boys' Home | Treatment of noise induced hearing loss |
| WO2015195605A1 (en) * | 2014-06-17 | 2015-12-23 | Teva Pharmaceutical Industries Ltd. | Transmucosal delivery of glatiramer acetate by oral patches |
| CN104844697B (zh) * | 2014-09-26 | 2018-10-23 | 深圳翰宇药业股份有限公司 | 醋酸格拉替雷的制备方法 |
| US9155775B1 (en) * | 2015-01-28 | 2015-10-13 | Teva Pharmaceutical Industries, Ltd. | Process for manufacturing glatiramer acetate product |
| CN107550853B (zh) * | 2016-06-30 | 2020-06-12 | 深圳翰宇药业股份有限公司 | 一种醋酸格拉替雷注射液的制备方法 |
| US12097292B2 (en) | 2016-08-28 | 2024-09-24 | Mapi Pharma Ltd. | Process for preparing microparticles containing glatiramer acetate |
| HRP20230738T1 (hr) | 2016-08-31 | 2023-10-27 | Mapi Pharma Ltd | Depo sustavi koji sadrže glatiramer acetat |
| US20180164221A1 (en) | 2016-12-07 | 2018-06-14 | Progenity Inc. | Gastrointestinal tract detection methods, devices and systems |
| JP2020515530A (ja) | 2017-03-26 | 2020-05-28 | マピ ファーマ リミテッド | 進行型の多発性硬化症を治療するためのグラチラマーデポシステム |
| CA3067681A1 (en) * | 2017-06-26 | 2019-01-03 | Institut Pasteur | Treatments to eliminate hiv reservoirs and reduce viral load |
| US20200306516A1 (en) | 2017-08-14 | 2020-10-01 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with glatiramer or a pharmaceutically acceptable salt thereof |
| KR102519053B1 (ko) | 2021-02-08 | 2023-04-06 | 건국대학교 산학협력단 | 염산가스의 농도 측정을 위한 수분 전처리 시스템 |
| KR102519054B1 (ko) | 2021-03-12 | 2023-04-06 | 건국대학교 산학협력단 | 나피온 드라이어와 수분 전처리장치의 결합시스템 |
| EP4415699A1 (en) * | 2021-10-11 | 2024-08-21 | Laboratoires Juvise Pharmaceuticals | Methods of treating multiple sclerosis |
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