HRP20241660T1 - Formulacija protutijela anti-cgrp - Google Patents
Formulacija protutijela anti-cgrp Download PDFInfo
- Publication number
- HRP20241660T1 HRP20241660T1 HRP20241660TT HRP20241660T HRP20241660T1 HR P20241660 T1 HRP20241660 T1 HR P20241660T1 HR P20241660T T HRP20241660T T HR P20241660TT HR P20241660 T HRP20241660 T HR P20241660T HR P20241660 T1 HRP20241660 T1 HR P20241660T1
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- Croatia
- Prior art keywords
- concentration
- formulation
- cgrp antibody
- pharmaceutical formulation
- seq
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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
-
- 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
-
- 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
- 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
- A61K47/22—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
- 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
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
-
- 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
- C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/515—Complete light chain, i.e. VL + CL
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Endocrinology (AREA)
- Pain & Pain Management (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (16)
1. Farmaceutska formulacija koja sadrži protutijelo anti-CGRP u koncentraciji od 40 mg/ml do 160 mg/ml, histidinski pufer u koncentraciji od 10 mM, NaCl u koncentraciji od 150 mM, PS-80 u koncentraciji od 0,05 % (w/v) i pH pri 5,0 do 6,5, pri čemu protutijelo anti-CGRP sadrži laki lanac (LC) i teški lanac (HC), sekvenca aminokiselina za laki lanac dana je u SEQ ID NO: 3 i sekvenca aminokiselina za teški lanac dana je u SEQ ID NO: 4.
2. Formulacija prema zahtjevu 1, pri čemu protutijelo anti-CGRP sadrži dva laka lanca i dva teška lanca, sekvenca aminokiselina svakog lakog lanca dana je u SEQ ID NO: 3 i sekvenca aminokiselina svakog teškog lanca dana je u SEQ ID NO: 4.
3. Formulacija prema zahtjevu 1 ili zahtjevu 2, pri čemu je koncentracija protutijela anti-CGRP od 50 mg/ml do 150 mg/ml.
4. Formulacija prema zahtjevu 1 ili zahtjevu 2, pri čemu je koncentracija protutijela anti-CGRP od 100 mg/ml do 160 mg/ml.
5. Formulacija prema zahtjevu 1 ili zahtjevu 2, pri čemu je koncentracija protutijela anti-CGRP odabrana iz skupine koja se sastoji od 40 mg/ml, 50 mg/ml, 100 mg/ml, 120 mg/ml i 150 mg/ml.
6. Formulacija prema bilo kojem od zahtjeva od 1 do 5, pri čemu je pH 5,8.
7. Formulacija prema bilo kojem od zahtjeva od 1 do 3, pri čemu je koncentracija protutijela anti-CGRP odabrana iz skupine koja se sastoji od 50 mg/ml, 100 mg/ml, 120 mg/ml i 150 mg/ml, koncentracija histidinskog pufera je 10 mM, koncentracija NaCl je 150 mM, a koncentracija PS-80 je 0,05 %, farmaceutska formulacija ima pH između 5,5 i 6,0.
8. Formulacija prema zahtjevu 7, pri čemu je navedena formulacija prikladna za supkutanu injekciju.
9. Farmaceutska formulacija prema bilo kojem od zahtjeva od 1 do 8 za upotrebu u liječenju ili prevenciji barem jedne od migrena, epizodne glavobolje, kronične glavobolje, kronične klaster glavobolje i epizodne klaster glavobolje.
10. Farmaceutska formulacija za upotrebu u skladu sa zahtjevom 9, pri čemu je doza protutijela anti-CGRP koja se daje pacijentu 300 mg.
11. Farmaceutska formulacija za upotrebu u skladu sa zahtjevom 9, pri čemu je doza protutijela anti-CGRP koja se daje pacijentu 240 mg.
12. Farmaceutska formulacija za upotrebu u skladu sa zahtjevom 9, pri čemu je doza protutijela anti-CGRP koja se daje pacijentu 120 mg.
13. Farmaceutska formulacija za upotrebu u skladu sa bilo kojim od zahtjeva 10 – 12, pri čemu se doza primjenjuje u mjesečnim intervalima.
14. Farmaceutska formulacija za upotrebu u skladu sa zahtjevom 11, pri čemu nakon doze od 240 mg slijedi mjesečna doza održavanja od 120 mg.
15. Farmaceutska formulacija u skladu sa zahtjevom 1 koja sadrži protutijelo anti-CGRP u koncentraciji od 120 mg/ml, histidinski pufer u koncentraciji od 10 mM, NaCl u koncentraciji od 150 mM i PS-80 u koncentraciji od 0,05 % (w/v), farmaceutska formulacija koja ima pH između 5,0 i 6,5, pri čemu protutijelo anti-CGRP sadrži dva laka lanca i dva teška lanca, sekvenca aminokiselina svakog lakog lanca dana je u SEQ ID NO: 3, i sekvenca aminokiselina svakog teškog lanca dana je u SEQ ID NO: 4.
16. Farmaceutska formulacija u skladu sa zahtjevom 15, pri čemu farmaceutska formulacija ima pH 5,8.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562180905P | 2015-06-17 | 2015-06-17 | |
| EP16729483.4A EP3310809B1 (en) | 2015-06-17 | 2016-06-08 | Anti-cgrp antibody formulation |
| PCT/US2016/036407 WO2016205037A1 (en) | 2015-06-17 | 2016-06-08 | Anti-cgrp antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20241660T1 true HRP20241660T1 (hr) | 2025-02-14 |
Family
ID=56131672
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20241660TT HRP20241660T1 (hr) | 2015-06-17 | 2016-06-08 | Formulacija protutijela anti-cgrp |
Country Status (31)
| Country | Link |
|---|---|
| US (3) | US11498959B2 (hr) |
| EP (2) | EP4470557A3 (hr) |
| JP (1) | JP6438599B2 (hr) |
| KR (1) | KR102000867B1 (hr) |
| CN (3) | CN114948847A (hr) |
| AR (1) | AR104847A1 (hr) |
| AU (1) | AU2016280555B2 (hr) |
| BR (1) | BR112017023374A2 (hr) |
| CA (1) | CA2984185A1 (hr) |
| DK (1) | DK3310809T3 (hr) |
| EA (1) | EA037580B1 (hr) |
| ES (1) | ES3000607T3 (hr) |
| FI (1) | FI3310809T3 (hr) |
| HR (1) | HRP20241660T1 (hr) |
| HU (1) | HUE069368T2 (hr) |
| IL (2) | IL292562A (hr) |
| JO (1) | JO3772B1 (hr) |
| LT (1) | LT3310809T (hr) |
| MA (1) | MA49726B1 (hr) |
| MD (1) | MD3310809T2 (hr) |
| MX (1) | MX395147B (hr) |
| MY (1) | MY184266A (hr) |
| NZ (1) | NZ737046A (hr) |
| PL (1) | PL3310809T3 (hr) |
| PT (1) | PT3310809T (hr) |
| RS (1) | RS66243B1 (hr) |
| SI (1) | SI3310809T1 (hr) |
| TW (1) | TWI725973B (hr) |
| UA (1) | UA120881C2 (hr) |
| WO (1) | WO2016205037A1 (hr) |
| ZA (1) | ZA201707324B (hr) |
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| US12279989B2 (en) | 2011-02-04 | 2025-04-22 | Seed Health, Inc. | Method and system for increasing beneficial bacteria and decreasing pathogenic bacteria in the oral cavity |
| US11951139B2 (en) | 2015-11-30 | 2024-04-09 | Seed Health, Inc. | Method and system for reducing the likelihood of osteoporosis |
| US11998479B2 (en) | 2011-02-04 | 2024-06-04 | Seed Health, Inc. | Method and system for addressing adverse effects on the oral microbiome and restoring gingival health caused by sodium lauryl sulphate exposure |
| US11951140B2 (en) | 2011-02-04 | 2024-04-09 | Seed Health, Inc. | Modulation of an individual's gut microbiome to address osteoporosis and bone disease |
| US12257272B2 (en) | 2015-12-24 | 2025-03-25 | Seed Health, Inc. | Method and system for reducing the likelihood of developing depression in an individual |
| US11844720B2 (en) | 2011-02-04 | 2023-12-19 | Seed Health, Inc. | Method and system to reduce the likelihood of dental caries and halitosis |
| US20170114122A1 (en) | 2015-10-23 | 2017-04-27 | Alderbio Holdings Llc | Regulation of glucose metabolism using anti-cgrp antibodies |
| US11998574B2 (en) | 2013-12-20 | 2024-06-04 | Seed Health, Inc. | Method and system for modulating an individual's skin microbiome |
| US11980643B2 (en) | 2013-12-20 | 2024-05-14 | Seed Health, Inc. | Method and system to modify an individual's gut-brain axis to provide neurocognitive protection |
| US12005085B2 (en) | 2013-12-20 | 2024-06-11 | Seed Health, Inc. | Probiotic method and composition for maintaining a healthy vaginal microbiome |
| US12246043B2 (en) | 2013-12-20 | 2025-03-11 | Seed Health, Inc. | Topical application to treat acne vulgaris |
| US11833177B2 (en) | 2013-12-20 | 2023-12-05 | Seed Health, Inc. | Probiotic to enhance an individual's skin microbiome |
| US11826388B2 (en) | 2013-12-20 | 2023-11-28 | Seed Health, Inc. | Topical application of Lactobacillus crispatus to ameliorate barrier damage and inflammation |
| US12329783B2 (en) | 2013-12-20 | 2025-06-17 | Seed Health, Inc. | Method and system to improve the health of a person's skin microbiome |
| US11969445B2 (en) | 2013-12-20 | 2024-04-30 | Seed Health, Inc. | Probiotic composition and method for controlling excess weight, obesity, NAFLD and NASH |
| US11839632B2 (en) | 2013-12-20 | 2023-12-12 | Seed Health, Inc. | Topical application of CRISPR-modified bacteria to treat acne vulgaris |
| KR102274964B1 (ko) | 2014-03-21 | 2021-07-09 | 테바 파마슈티컬스 인터내셔널 게엠베하 | 칼시토닌 유전자-관련 펩티드에 대한 길항제 항체 및 그의 사용 방법 |
| US10556945B2 (en) | 2014-03-21 | 2020-02-11 | Teva Pharmaceuticals International Gmbh | Antagonist antibodies directed against calcitonin gene-related peptide and methods using same |
| AR104847A1 (es) * | 2015-06-17 | 2017-08-16 | Lilly Co Eli | Formulación de anticuerpo anti-cgrp |
| CA3037661A1 (en) * | 2016-09-23 | 2018-03-29 | Teva Pharmaceuticals International Gmbh | Treating cluster headache |
| KR20190066607A (ko) | 2016-09-23 | 2019-06-13 | 테바 파마슈티컬스 인터내셔널 게엠베하 | 불응성 편두통의 치료 |
| CN110621343A (zh) | 2017-03-02 | 2019-12-27 | 贝丝以色列女执事医疗中心 | 选择对针对降钙素基因相关肽的抗体有反应的头痛患者 |
| TWI754772B (zh) * | 2017-09-06 | 2022-02-11 | 美商美國禮來大藥廠 | 用於治療偏頭痛之拉米迪坦(lasmiditan)與cgrp拮抗劑之組合療法 |
| SG11202009629YA (en) * | 2018-04-02 | 2020-10-29 | Amgen Inc | Erenumab compositions and uses thereof |
| WO2019231800A1 (en) * | 2018-05-31 | 2019-12-05 | Eli Lilly And Company | Anti-cgrp antibodies for treating menstrual-related migraines |
| IL281693B2 (en) * | 2018-09-20 | 2025-01-01 | Teva Pharmaceuticals Int Gmbh | Injection spring for old prefilled syringe and auto injector |
| JOP20210156A1 (ar) | 2019-01-08 | 2023-01-30 | H Lundbeck As | علاج إسعافي وعلاج سريع للصداع باستخدام أجسام مضادة لـ cgrp |
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2016
- 2016-06-01 AR ARP160101603A patent/AR104847A1/es not_active Application Discontinuation
- 2016-06-02 TW TW105117447A patent/TWI725973B/zh active
- 2016-06-05 JO JOP/2016/0111A patent/JO3772B1/ar active
- 2016-06-08 SI SI201631867T patent/SI3310809T1/sl unknown
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