AU2019321568B2 - Methods of reducing the need for peripheral arterial revascularization in a statin-treated subject - Google Patents

Methods of reducing the need for peripheral arterial revascularization in a statin-treated subject Download PDF

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AU2019321568B2
AU2019321568B2 AU2019321568A AU2019321568A AU2019321568B2 AU 2019321568 B2 AU2019321568 B2 AU 2019321568B2 AU 2019321568 A AU2019321568 A AU 2019321568A AU 2019321568 A AU2019321568 A AU 2019321568A AU 2019321568 B2 AU2019321568 B2 AU 2019321568B2
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AU2019321568A1 (en
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Craig GRANOWITZ
Sephy PHILIP
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Amarin Pharmaceuticals Ireland Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
    • A61K31/232Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms having three or more double bonds, e.g. etretinate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/366Lactones having six-membered rings, e.g. delta-lactones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/397Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
AU2019321568A 2018-08-17 2019-08-15 Methods of reducing the need for peripheral arterial revascularization in a statin-treated subject Active AU2019321568B2 (en)

Priority Applications (1)

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AU2025202801A AU2025202801A1 (en) 2018-08-17 2025-04-22 Methods of reducing the need for peripheral arterial revascularization in a statin-treated subject

Applications Claiming Priority (3)

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US201862719404P 2018-08-17 2018-08-17
US62/719,404 2018-08-17
PCT/US2019/046710 WO2020037153A1 (en) 2018-08-17 2019-08-15 Methods of reducing the need for peripheral arterial revascularization in a statin-treated subject

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AU2019321568A1 AU2019321568A1 (en) 2021-03-11
AU2019321568B2 true AU2019321568B2 (en) 2025-01-30

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AU2025202801A Pending AU2025202801A1 (en) 2018-08-17 2025-04-22 Methods of reducing the need for peripheral arterial revascularization in a statin-treated subject

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US (2) US20220362200A1 (https=)
EP (1) EP3836914A4 (https=)
JP (1) JP2021534185A (https=)
KR (1) KR20210047312A (https=)
CN (1) CN112912071A (https=)
AU (2) AU2019321568B2 (https=)
BR (1) BR112021002884A2 (https=)
CL (3) CL2021000400A1 (https=)
EA (1) EA202190547A1 (https=)
IL (1) IL280643A (https=)
MA (1) MA52680A1 (https=)
MX (1) MX2021001906A (https=)
NI (1) NI202100009A (https=)
PH (1) PH12021550328A1 (https=)
SG (1) SG11202101562UA (https=)
TN (1) TN2021000028A1 (https=)
WO (1) WO2020037153A1 (https=)

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ624963A (en) 2009-04-29 2016-07-29 Amarin Pharmaceuticals Ie Ltd Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same
SG10201605794PA (en) 2009-04-29 2016-09-29 Amarin Pharmaceuticals Ie Ltd Stable Pharmaceutical Composition And Methods Of Using Same
EP3318255B1 (en) 2009-06-15 2021-03-10 Amarin Pharmaceuticals Ireland Limited Compositions and methods for treating stroke in a subject on concomitant statin therapy
AU2010298222B2 (en) 2009-09-23 2017-01-05 Amarin Pharmaceuticals Ireland Limited Pharmaceutical composition comprising omega-3 fatty acid and hydroxy-derivative of a statin and methods of using same
US11712429B2 (en) 2010-11-29 2023-08-01 Amarin Pharmaceuticals Ireland Limited Low eructation composition and methods for treating and/or preventing cardiovascular disease in a subject with fish allergy/hypersensitivity
NZ744990A (en) 2010-11-29 2019-10-25 Amarin Pharmaceuticals Ie Ltd Low eructation composition and methods for treating and/or preventing cardiovascular disease in a subject with fish allergy/hypersensitivity
US11291643B2 (en) 2011-11-07 2022-04-05 Amarin Pharmaceuticals Ireland Limited Methods of treating hypertriglyceridemia
ES2891473T3 (es) 2012-01-06 2022-01-28 Amarin Pharmaceuticals Ie Ltd Composiciones y métodos para reducir los niveles de alta sensibilidad (hs-CRP) en un sujeto
NZ727849A (en) 2012-06-29 2018-06-29 Amarin Pharmaceuticals Ie Ltd Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
WO2014074552A2 (en) 2012-11-06 2014-05-15 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering triglycerides without raising ldl-c levels in a subject on concomitant statin therapy
US20140187633A1 (en) 2012-12-31 2014-07-03 Amarin Pharmaceuticals Ireland Limited Methods of treating or preventing nonalcoholic steatohepatitis and/or primary biliary cirrhosis
US9452151B2 (en) 2013-02-06 2016-09-27 Amarin Pharmaceuticals Ireland Limited Methods of reducing apolipoprotein C-III
US9624492B2 (en) 2013-02-13 2017-04-18 Amarin Pharmaceuticals Ireland Limited Compositions comprising eicosapentaenoic acid and mipomersen and methods of use thereof
US20140271841A1 (en) 2013-03-15 2014-09-18 Amarin Pharmaceuticals Ireland Limited Pharmaceutical composition comprising eicosapentaenoic acid and derivatives thereof and a statin
US10966968B2 (en) 2013-06-06 2021-04-06 Amarin Pharmaceuticals Ireland Limited Co-administration of rosiglitazone and eicosapentaenoic acid or a derivative thereof
US20150065572A1 (en) 2013-09-04 2015-03-05 Amarin Pharmaceuticals Ireland Limited Methods of treating or preventing prostate cancer
US9585859B2 (en) 2013-10-10 2017-03-07 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
US10561631B2 (en) 2014-06-11 2020-02-18 Amarin Pharmaceuticals Ireland Limited Methods of reducing RLP-C
WO2015195662A1 (en) 2014-06-16 2015-12-23 Amarin Pharmaceuticals Ireland Limited Methods of reducing or preventing oxidation of small dense ldl or membrane polyunsaturated fatty acids
TW201900160A (zh) 2017-05-19 2019-01-01 愛爾蘭商艾瑪琳製藥愛爾蘭有限公司 用於降低腎功能下降之個體中的三酸甘油酯之組合物及方法
US11058661B2 (en) 2018-03-02 2021-07-13 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy and having hsCRP levels of at least about 2 mg/L
US12430998B2 (en) 2018-09-14 2025-09-30 Avive Solutions, Inc. Device based responder network activation and virtual assistant integration
US11645899B2 (en) 2018-09-14 2023-05-09 Avive Solutions, Inc. Responder network
US11640755B2 (en) 2018-09-14 2023-05-02 Avive Solutions, Inc. Real time defibrillator incident data
LT3750536T (lt) 2018-09-24 2026-03-25 Amarin Pharmaceuticals Ireland Limited Širdies ir kraujagyslių sistemos reiškinių rizikos subjekto organizme sumažinimo būdai
BR112022009189A2 (pt) 2019-11-12 2022-07-26 Amarin Pharmaceuticals Ie Ltd Métodos para reduzir o risco de eventos cardiovasculares em um sujeito com fibrilação atrial e/ou palpitação atrial
WO2021102246A1 (en) * 2019-11-21 2021-05-27 Avive Solutions, Inc. Device based responder network activation and virtual assistant integration
AU2022263358A1 (en) 2021-04-21 2023-11-30 Amarin Pharmaceuticals Ireland Limited Methods of reducing the risk of heart failure
CA3217098A1 (en) * 2021-04-29 2022-11-03 Richard Louis Dunbar Compositions comprising epa and methods of using the same for treating and/or preventing endothelial dysfunction in a subject

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140322314A1 (en) * 2013-04-29 2014-10-30 Matinas Biopharma, Inc. Omega-3 Fatty Acid Formulations for Use as Pharmaceutical Treatment
US9603826B2 (en) * 2012-06-29 2017-03-28 Amarin Pharmaceuticals Ireland Limited Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
US20170333377A1 (en) * 2016-03-15 2017-11-23 Amarin Pharmaceuticals Ireland Limited Methods of Reducing or Preventing Oxidation of Small Dense LDL or Membrane Polyunsaturated Fatty Acids
EP3275438A1 (en) * 2016-07-29 2018-01-31 KOWA Co., Ltd. Methods of preventing cardiovascular events in residual risk dyslipidemic populations

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090239927A1 (en) * 2004-12-06 2009-09-24 George Bobotas Statin and Omega-3 Fatty Acids For Lipid Therapy
JP2009544701A (ja) * 2006-07-21 2009-12-17 リライアント・ファーマシューティカルズ・インコーポレイテッド オメガ3脂肪酸を含む組成物、ならびに末梢動脈障害および間欠性跛行を処置するためのそれらの使用
AU2015231713B2 (en) * 2014-03-17 2020-11-19 Regeneron Pharmaceuticals, Inc. Methods for reducing cardiovascular risk

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9603826B2 (en) * 2012-06-29 2017-03-28 Amarin Pharmaceuticals Ireland Limited Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
US20140322314A1 (en) * 2013-04-29 2014-10-30 Matinas Biopharma, Inc. Omega-3 Fatty Acid Formulations for Use as Pharmaceutical Treatment
US20170333377A1 (en) * 2016-03-15 2017-11-23 Amarin Pharmaceuticals Ireland Limited Methods of Reducing or Preventing Oxidation of Small Dense LDL or Membrane Polyunsaturated Fatty Acids
EP3275438A1 (en) * 2016-07-29 2018-01-31 KOWA Co., Ltd. Methods of preventing cardiovascular events in residual risk dyslipidemic populations

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PETER P. TOTH ET AL: JOURNAL OF THE AMERICAN HEART ASSOCIATION, vol. 7, no. 15, 7 August 2018 (2018-08-07), pages 1 - 11, XP055686628, DOI: 10.1161/JAHA.118.008740 *

Also Published As

Publication number Publication date
EP3836914A1 (en) 2021-06-23
EP3836914A4 (en) 2022-05-18
US20250186386A1 (en) 2025-06-12
KR20210047312A (ko) 2021-04-29
BR112021002884A2 (pt) 2021-05-11
IL280643A (en) 2021-03-25
US20220362200A1 (en) 2022-11-17
EA202190547A1 (ru) 2021-04-27
WO2020037153A1 (en) 2020-02-20
MX2021001906A (es) 2021-04-28
SG11202101562UA (en) 2021-03-30
TN2021000028A1 (en) 2022-10-03
NI202100009A (es) 2021-06-22
CL2021003221A1 (es) 2022-07-22
MA52680A1 (fr) 2021-11-30
AU2025202801A9 (en) 2026-03-05
CA3109774A1 (en) 2020-02-20
PH12021550328A1 (en) 2021-10-04
CL2021003222A1 (es) 2022-07-22
CL2021000400A1 (es) 2021-07-02
AU2019321568A1 (en) 2021-03-11
AU2025202801A1 (en) 2025-05-08
CN112912071A (zh) 2021-06-04
JP2021534185A (ja) 2021-12-09

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