JP2017506626A - 中程度用量スタチン療法により適切に管理されない高コレステロール血症を有する患者を処置するための方法 - Google Patents

中程度用量スタチン療法により適切に管理されない高コレステロール血症を有する患者を処置するための方法 Download PDF

Info

Publication number
JP2017506626A
JP2017506626A JP2016550471A JP2016550471A JP2017506626A JP 2017506626 A JP2017506626 A JP 2017506626A JP 2016550471 A JP2016550471 A JP 2016550471A JP 2016550471 A JP2016550471 A JP 2016550471A JP 2017506626 A JP2017506626 A JP 2017506626A
Authority
JP
Japan
Prior art keywords
antibody
patient
dose
weeks
pcsk9
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2016550471A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017506626A5 (enExample
Inventor
ロバート・シー・ポーディー
ウィリアム・ジェイ・サシーラ
ジョイス・ビー・ハープ
コリンヌ・アノトン
ローレンス・ベサック
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of JP2017506626A publication Critical patent/JP2017506626A/ja
Publication of JP2017506626A5 publication Critical patent/JP2017506626A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K31/495Heterocyclic 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
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2016550471A 2014-02-14 2015-02-12 中程度用量スタチン療法により適切に管理されない高コレステロール血症を有する患者を処置するための方法 Pending JP2017506626A (ja)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US201461939857P 2014-02-14 2014-02-14
US61/939,857 2014-02-14
US201462000162P 2014-05-19 2014-05-19
US62/000,162 2014-05-19
US201462025094P 2014-07-16 2014-07-16
US62/025,094 2014-07-16
US201462052227P 2014-09-18 2014-09-18
US62/052,227 2014-09-18
EP14306729 2014-10-29
EP14306729.6 2014-10-29
PCT/US2015/015633 WO2015123423A2 (en) 2014-02-14 2015-02-12 Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy

Publications (2)

Publication Number Publication Date
JP2017506626A true JP2017506626A (ja) 2017-03-09
JP2017506626A5 JP2017506626A5 (enExample) 2018-03-15

Family

ID=51870958

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016550471A Pending JP2017506626A (ja) 2014-02-14 2015-02-12 中程度用量スタチン療法により適切に管理されない高コレステロール血症を有する患者を処置するための方法

Country Status (10)

Country Link
US (2) US20150231236A1 (enExample)
EP (1) EP3104879A2 (enExample)
JP (1) JP2017506626A (enExample)
KR (1) KR20160115939A (enExample)
CN (1) CN106029096A (enExample)
AU (1) AU2015217118A1 (enExample)
CA (1) CA2939507A1 (enExample)
EA (1) EA201691320A1 (enExample)
MX (1) MX2016010504A (enExample)
WO (1) WO2015123423A2 (enExample)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
CN110711248A (zh) * 2011-01-28 2020-01-21 赛诺菲生物技术公司 包含针对pcsk9的人抗体的药物组合物
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
ES2992345T3 (es) 2011-09-16 2024-12-11 Regeneron Pharma Métodos para reducir los niveles de lipoproteína(a) mediante la administración de un inhibidor de la proproteína convertasa subtilisina kexina-9 (PCSK9)
US9255154B2 (en) 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
US10058630B2 (en) 2012-10-22 2018-08-28 Concievalve, Llc Methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
US20140257473A1 (en) * 2012-10-22 2014-09-11 Nalini Marie Rajamannan Methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
US10111953B2 (en) 2013-05-30 2018-10-30 Regeneron Pharmaceuticals, Inc. Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9)
AU2014274844B2 (en) 2013-06-07 2019-11-28 Regeneron Pharmaceuticals, Inc. Methods for inhibiting atherosclerosis by administering an inhibitor of PCSK9
EP3068803B1 (en) 2013-11-12 2021-01-20 Sanofi Biotechnology Dosing regimens for use with pcsk9 inhibitors
US20230374155A1 (en) * 2014-05-15 2023-11-23 Rani Therapeutics, Llc Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
CN107072955B (zh) 2014-05-15 2021-06-18 拉尼医疗有限公司 包含多肽和/或蛋白质的固体块的药物组合物和该固体块的制备方法
US10689460B2 (en) * 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US20170198059A1 (en) * 2014-07-14 2017-07-13 Amgen Inc. Crystalline antibody formulations
RU2735521C2 (ru) 2014-07-16 2020-11-03 Санофи Байотекнолоджи Способы лечения пациентов с гетерозиготной семейной гиперхолестеринемией (hefh)
US10772956B2 (en) 2015-08-18 2020-09-15 Regeneron Pharmaceuticals, Inc. Methods for reducing or eliminating the need for lipoprotein apheresis in patients with hyperlipidemia by administering alirocumab
CN108401419A (zh) 2015-09-08 2018-08-14 因库博实验室有限责任公司 使用可吞服药物递送装置递送到肠道内腔中的pcsk9抗体制剂
US10939164B2 (en) 2016-05-10 2021-03-02 Rovi Guides, Inc. Method and system for transferring an interactive feature to another device
EP3474780A4 (en) * 2016-06-27 2020-02-26 Concievalve LLC METHODS OF INHIBITING STENOSIS, OBSTRUCTING OR CALCIFYING A CARDIAC VALVE WITH STENT OR BIOPROSTHESIS
EP3609532A1 (en) 2017-04-13 2020-02-19 Cadila Healthcare Limited Novel peptide based pcsk9 vaccine
GB201720162D0 (en) 2017-12-04 2018-01-17 Univ Oxford Innovation Ltd Method
EP4470609A3 (en) 2019-01-18 2025-03-12 Astrazeneca AB Pcsk9 inhibitors and methods of use thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012101253A1 (en) * 2011-01-28 2012-08-02 Sanofi Pharmaceutical compositions comprising human antibodies to pcsk9
WO2013039969A1 (en) * 2011-09-16 2013-03-21 Regeneron Pharmaceuticals, Inc. METHODS FOR REDUCING LIPOPROTEIN(a) LEVELS BY ADMINISTERING AN INHIBITOR OF PROPROTEIN CONVERTASE SUBTILISIN KEXIN-9 (PCSK9)
WO2013169886A1 (en) * 2012-05-08 2013-11-14 Alderbio Holdings Llc Anti-pcsk9 antibodies and use thereof
WO2013177536A2 (en) * 2012-05-25 2013-11-28 Catabasis Pharmaceuticals, Inc. Methods of lowering proprotein convertase subtilisin/kexin type 9 (pcsk9)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6596541B2 (en) 2000-10-31 2003-07-22 Regeneron Pharmaceuticals, Inc. Methods of modifying eukaryotic cells
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012101253A1 (en) * 2011-01-28 2012-08-02 Sanofi Pharmaceutical compositions comprising human antibodies to pcsk9
WO2013039969A1 (en) * 2011-09-16 2013-03-21 Regeneron Pharmaceuticals, Inc. METHODS FOR REDUCING LIPOPROTEIN(a) LEVELS BY ADMINISTERING AN INHIBITOR OF PROPROTEIN CONVERTASE SUBTILISIN KEXIN-9 (PCSK9)
WO2013169886A1 (en) * 2012-05-08 2013-11-14 Alderbio Holdings Llc Anti-pcsk9 antibodies and use thereof
WO2013177536A2 (en) * 2012-05-25 2013-11-28 Catabasis Pharmaceuticals, Inc. Methods of lowering proprotein convertase subtilisin/kexin type 9 (pcsk9)

Also Published As

Publication number Publication date
KR20160115939A (ko) 2016-10-06
WO2015123423A3 (en) 2015-10-08
CA2939507A1 (en) 2015-08-20
MX2016010504A (es) 2016-12-09
AU2015217118A1 (en) 2016-08-18
US20180296672A1 (en) 2018-10-18
EP3104879A2 (en) 2016-12-21
EA201691320A1 (ru) 2016-11-30
WO2015123423A2 (en) 2015-08-20
CN106029096A (zh) 2016-10-12
US20150231236A1 (en) 2015-08-20

Similar Documents

Publication Publication Date Title
JP6994484B2 (ja) 高脂血症を処置するためのpcsk9阻害剤の使用
JP2017506626A (ja) 中程度用量スタチン療法により適切に管理されない高コレステロール血症を有する患者を処置するための方法
US20240261400A1 (en) Methods for reducing or eliminating the need for lipoprotein apheresis in patients with hyperlipidemia by administering alirocumab
JP2022133396A (ja) ヘテロ接合性家族性高コレステロール血症(heFH)を有する患者を処置するための方法
JP6912374B2 (ja) 高コレステロール血症を有する高心血管リスク患者を処置するための方法
US10428157B2 (en) Dosing regimens for use with PCSK9 inhibitors
KR20160132459A (ko) 심혈관 위험을 감소시키는 방법
JP2020143156A (ja) 心血管リスクを低減させる方法
ES2779126T3 (es) Uso de un inhibidor de PCSK9 para tratar hiperlipidemia
JP7104108B2 (ja) ヘテロ接合性家族性高コレステロール血症(heFH)を有する患者を処置するための方法
HK40033729A (en) Use of a pcsk9 inhibitor to treat hyperlipidemia
HK40033729B (en) Use of a pcsk9 inhibitor to treat hyperlipidemia
EA041556B1 (ru) Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией подвергающихся аферезу липопротеинов

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180202

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180202

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20181030

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20190122

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190417

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20190820