HRP20221150T1 - Semaglutid u kardiovaskularnim stanjima - Google Patents
Semaglutid u kardiovaskularnim stanjima Download PDFInfo
- Publication number
- HRP20221150T1 HRP20221150T1 HRP20221150TT HRP20221150T HRP20221150T1 HR P20221150 T1 HRP20221150 T1 HR P20221150T1 HR P20221150T T HRP20221150T T HR P20221150TT HR P20221150 T HRP20221150 T HR P20221150T HR P20221150 T1 HRP20221150 T1 HR P20221150T1
- Authority
- HR
- Croatia
- Prior art keywords
- semaglutide
- pharmaceutical preparation
- accordance
- preparation intended
- pharmaceutical composition
- Prior art date
Links
- DLSWIYLPEUIQAV-UHFFFAOYSA-N Semaglutide Chemical compound CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CCC(O)=O)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(O)=O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)C(C)(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CCCNC(N)=N)C(=O)NCC(O)=O DLSWIYLPEUIQAV-UHFFFAOYSA-N 0.000 title claims 10
- 229950011186 semaglutide Drugs 0.000 title claims 10
- 108010060325 semaglutide Proteins 0.000 title claims 10
- 230000002526 effect on cardiovascular system Effects 0.000 title claims 6
- 239000000825 pharmaceutical preparation Substances 0.000 claims 11
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 208000010125 myocardial infarction Diseases 0.000 claims 6
- 206010019280 Heart failures Diseases 0.000 claims 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 231100001160 nonlethal Toxicity 0.000 claims 3
- 238000000034 method Methods 0.000 claims 2
- 239000000902 placebo Substances 0.000 claims 2
- 229940068196 placebo Drugs 0.000 claims 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 1
- 208000007814 Unstable Angina Diseases 0.000 claims 1
- 230000002411 adverse Effects 0.000 claims 1
- 230000007211 cardiovascular event Effects 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 230000001934 delay Effects 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 229960004063 propylene glycol Drugs 0.000 claims 1
- 235000013772 propylene glycol Nutrition 0.000 claims 1
- 230000000250 revascularization Effects 0.000 claims 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 1
Classifications
-
- 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
- A61K38/22—Hormones
- A61K38/26—Glucagons
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Emergency Medicine (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Peptides Or Proteins (AREA)
Claims (15)
1. Farmaceutski pripravak namijenjen upotrebi u postupku smanjivanja rizika od velike štetne kardiovaskularne pojave (MACE) kod subjekata s dijabetesom melitusom tipa 2 i visokim kardiovaskularnim rizikom, naznačen time što se navedeni MACE bira iz skupine koju čine:
a. kardiovaskularna (CV) smrt,
b. nesmrtonosni infarkt miokarda (MI),
c. nesmrtonosni inzult,
d. revaskularizacija,
e. hospitalizacija zbog zatajenja srca, i
f. hospitalizacija zbog nestabilne angine pektoris; gdje
navedeni farmaceutski pripravak se sastoji od semaglutida i jednog ili više farmaceutski prihvatljivih pomoćna sredstva.
2. Farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što se navedeni MACE bira iz skupine koju čine:
a. kardiovaskularna (CV) smrt,
b. nesmrtonosni infarkt miokarda (MI), te
c. nesmrtonosni inzult.
3. Farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je navedeni MACE nesmrtonosni inzult.
4. Farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 2, naznačen time što navedeni MACE se smanjuje za od otprilike 20% do otprilike 30% u usporedbi s placebom, primjerice smanjuje se otprilike 26% u usporedbi s placebom.
5. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je subjekt čovjek.
6. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je doziranje navedenog semaglutida u rasponu od 0,01 do 10 mg ili u rasponu od 0,1 do 5,0 mg.
7. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se navedeni semaglutid primijenjuje jednom tjedno ili češće, primjerice jednom dnevno.
8. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se navedeni semaglutid primijenjuje u količini u rasponu od 0,05-2,0 mg tjedno, primjerice 0,5 ili 1,0 mg tjedno.
9. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se navedeni semaglutid primijenjuje jednom tjedno u količini od 0,5 ili 1,0 mg.
10. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni farmaceutski pripravak sadrži otprilike 0,1-20 mg/ml semaglutida i ima pH u rasponu od 7,0-9,0.
11. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni farmaceutski pripravak sadrži otprilike 0,1-20 mg/ml semaglutida, otprilike 2-15 mM fosfatnog pufera, otprilike 2-25 mg/ml propilen-glikola, otprilike 1-18 mg/ml fenola, te ima pH u rasponu od 7,0-9,0.
12. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni subjekt ima BMI od najviše 30 kg/m2.
13. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni subjekt nema zatajenje srca ili ima zatajenje srca NYHA klase I.
14. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni subjekt nema zatajenje srca NYHA klase II, III ili IV.
15. Farmaceutski pripravak namijenjen upotrebi u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se navedeni semaglutid primijenjuje kao kronično liječenje u kojem se semaglutid primijenjuje u trajanju od najmanje 16 mjeseci, primjerice najmanje 30 mjeseci, te gdje navedeni postupak smanjuje ili odgađa nesmrtonosni infarkt miokarda (MI).
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16167458 | 2016-04-28 | ||
| EP16188262 | 2016-09-12 | ||
| EP17721109.1A EP3448416B1 (en) | 2016-04-28 | 2017-04-28 | Semaglutide in cardiovascular conditions |
| PCT/EP2017/060160 WO2017186896A1 (en) | 2016-04-28 | 2017-04-28 | Semaglutide in cardiovascular conditions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20221150T1 true HRP20221150T1 (hr) | 2022-11-25 |
Family
ID=58668875
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221150TT HRP20221150T1 (hr) | 2016-04-28 | 2017-04-28 | Semaglutid u kardiovaskularnim stanjima |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US20190134162A1 (hr) |
| EP (1) | EP3448416B1 (hr) |
| JP (1) | JP7221694B2 (hr) |
| KR (2) | KR20220147712A (hr) |
| CN (1) | CN109069589B (hr) |
| AU (1) | AU2017256774A1 (hr) |
| BR (1) | BR112018072020A2 (hr) |
| CA (1) | CA3022535A1 (hr) |
| CL (1) | CL2018003045A1 (hr) |
| DK (1) | DK3448416T3 (hr) |
| ES (1) | ES2928007T3 (hr) |
| HR (1) | HRP20221150T1 (hr) |
| HU (1) | HUE060040T2 (hr) |
| IL (1) | IL262390B1 (hr) |
| MA (1) | MA44762A (hr) |
| MX (1) | MX2018012700A (hr) |
| PH (1) | PH12018502274A1 (hr) |
| PL (1) | PL3448416T3 (hr) |
| RS (1) | RS63630B1 (hr) |
| RU (1) | RU2768283C2 (hr) |
| SI (1) | SI3448416T1 (hr) |
| WO (1) | WO2017186896A1 (hr) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HRP20221150T1 (hr) | 2016-04-28 | 2022-11-25 | Novo Nordisk A/S | Semaglutid u kardiovaskularnim stanjima |
| CN111050750A (zh) | 2017-08-24 | 2020-04-21 | 诺沃挪第克公司 | Glp-1组合物及其用途 |
| SG11202103137WA (en) * | 2018-10-26 | 2021-04-29 | Novo Nordisk As | Stable semaglutide compositions and uses thereof |
| EP3897582A1 (en) * | 2018-12-21 | 2021-10-27 | Novo Nordisk A/S | Process of spray drying of glp-1 peptide |
| MX2022009523A (es) * | 2020-02-18 | 2022-09-09 | Novo Nordisk As | Formulaciones farmaceuticas. |
| CN114699510A (zh) * | 2021-12-29 | 2022-07-05 | 浙江湃肽生物有限公司 | 一种司美格鲁肽微针阵列及其制备方法 |
| WO2023238017A1 (en) * | 2022-06-08 | 2023-12-14 | Zydus Lifesciences Limited | Reusable multi-dose, variable dose, single pen injector for type 2 diabetes and weight management |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005535569A (ja) * | 2002-04-04 | 2005-11-24 | ノボ・ノルデイスク・エー／エス | Ｇｌｐ−１アゴニスト及び心臓血管合併症 |
| TWI372629B (en) | 2005-03-18 | 2012-09-21 | Novo Nordisk As | Acylated glp-1 compounds |
| MX341025B (es) * | 2010-05-05 | 2016-08-04 | Boehringer Ingelheim Int Gmbh * | Terapia de combinacion. |
| HUE036066T2 (hu) * | 2010-12-16 | 2018-06-28 | Novo Nordisk As | GLP-1 agonistát és N-(8-(2-hidroxibenzoil)amino)kaprilsav sóját tartalmazó szilárd készítmények |
| US20130035281A1 (en) | 2011-02-09 | 2013-02-07 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, methods for treating and uses thereof |
| ES2626013T3 (es) * | 2011-09-06 | 2017-07-21 | Novo Nordisk A/S | Derivados de GLP-1 |
| CN105722526B (zh) * | 2013-11-15 | 2020-12-08 | 诺和诺德股份有限公司 | 选择性pyy化合物及其用途 |
| HRP20221150T1 (hr) | 2016-04-28 | 2022-11-25 | Novo Nordisk A/S | Semaglutid u kardiovaskularnim stanjima |
-
2017
- 2017-04-28 HR HRP20221150TT patent/HRP20221150T1/hr unknown
- 2017-04-28 JP JP2018556411A patent/JP7221694B2/ja active Active
- 2017-04-28 RU RU2018140900A patent/RU2768283C2/ru active
- 2017-04-28 MX MX2018012700A patent/MX2018012700A/es unknown
- 2017-04-28 AU AU2017256774A patent/AU2017256774A1/en active Pending
- 2017-04-28 ES ES17721109T patent/ES2928007T3/es active Active
- 2017-04-28 DK DK17721109.1T patent/DK3448416T3/da active
- 2017-04-28 SI SI201731219T patent/SI3448416T1/sl unknown
- 2017-04-28 BR BR112018072020-8A patent/BR112018072020A2/pt unknown
- 2017-04-28 US US16/097,032 patent/US20190134162A1/en active Pending
- 2017-04-28 WO PCT/EP2017/060160 patent/WO2017186896A1/en active Application Filing
- 2017-04-28 KR KR1020227036550A patent/KR20220147712A/ko not_active Application Discontinuation
- 2017-04-28 CA CA3022535A patent/CA3022535A1/en active Pending
- 2017-04-28 MA MA044762A patent/MA44762A/fr unknown
- 2017-04-28 EP EP17721109.1A patent/EP3448416B1/en active Active
- 2017-04-28 KR KR1020187033310A patent/KR20180135012A/ko active Application Filing
- 2017-04-28 CN CN201780026303.2A patent/CN109069589B/zh active Active
- 2017-04-28 RS RS20220901A patent/RS63630B1/sr unknown
- 2017-04-28 PL PL17721109.1T patent/PL3448416T3/pl unknown
- 2017-04-28 HU HUE17721109A patent/HUE060040T2/hu unknown
-
2018
- 2018-10-15 IL IL262390A patent/IL262390B1/en unknown
- 2018-10-25 CL CL2018003045A patent/CL2018003045A1/es unknown
- 2018-10-25 PH PH12018502274A patent/PH12018502274A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BR112018072020A2 (pt) | 2019-02-12 |
| WO2017186896A1 (en) | 2017-11-02 |
| MA44762A (fr) | 2019-03-06 |
| HUE060040T2 (hu) | 2023-01-28 |
| RU2768283C2 (ru) | 2022-03-23 |
| EP3448416B1 (en) | 2022-08-10 |
| IL262390B1 (en) | 2023-05-01 |
| CN109069589A (zh) | 2018-12-21 |
| RS63630B1 (sr) | 2022-10-31 |
| SI3448416T1 (sl) | 2022-10-28 |
| DK3448416T3 (da) | 2022-10-03 |
| RU2018140900A (ru) | 2020-05-28 |
| KR20180135012A (ko) | 2018-12-19 |
| EP3448416A1 (en) | 2019-03-06 |
| JP2019514925A (ja) | 2019-06-06 |
| RU2018140900A3 (hr) | 2020-09-28 |
| AU2017256774A1 (en) | 2018-11-01 |
| ES2928007T3 (es) | 2022-11-14 |
| IL262390A (en) | 2018-12-31 |
| CL2018003045A1 (es) | 2018-12-14 |
| KR20220147712A (ko) | 2022-11-03 |
| CN109069589B (zh) | 2022-09-06 |
| CA3022535A1 (en) | 2017-11-02 |
| MX2018012700A (es) | 2019-01-30 |
| PL3448416T3 (pl) | 2022-11-07 |
| US20190134162A1 (en) | 2019-05-09 |
| PH12018502274A1 (en) | 2019-09-09 |
| JP7221694B2 (ja) | 2023-02-14 |
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