CN106029096A - 用于治疗具有未被中等剂量他汀疗法充分控制的高胆固醇血症的患者的方法 - Google Patents

用于治疗具有未被中等剂量他汀疗法充分控制的高胆固醇血症的患者的方法 Download PDF

Info

Publication number
CN106029096A
CN106029096A CN201580008411.8A CN201580008411A CN106029096A CN 106029096 A CN106029096 A CN 106029096A CN 201580008411 A CN201580008411 A CN 201580008411A CN 106029096 A CN106029096 A CN 106029096A
Authority
CN
China
Prior art keywords
patient
dose
antibody
pcsk9
ldl
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
CN201580008411.8A
Other languages
English (en)
Chinese (zh)
Inventor
R·C·波尔蒂
W·J·萨赛拉
J·B·哈普
C·阿诺廷
L·贝萨克
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.)
Sanofi Biotechnology SAS
Regeneron Pharmaceuticals Inc
Original Assignee
Sanofi Biotechnology SAS
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 Sanofi Biotechnology SAS, Regeneron Pharmaceuticals Inc filed Critical Sanofi Biotechnology SAS
Publication of CN106029096A publication Critical patent/CN106029096A/zh
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic 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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • A61K2039/545—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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (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)
CN201580008411.8A 2014-02-14 2015-02-12 用于治疗具有未被中等剂量他汀疗法充分控制的高胆固醇血症的患者的方法 Pending CN106029096A (zh)

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 (1)

Publication Number Publication Date
CN106029096A true CN106029096A (zh) 2016-10-12

Family

ID=51870958

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201580008411.8A Pending CN106029096A (zh) 2014-02-14 2015-02-12 用于治疗具有未被中等剂量他汀疗法充分控制的高胆固醇血症的患者的方法

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).
MX347602B (es) 2011-01-28 2017-05-03 Sanofi Biotechnology Composiciones farmaceuticas que comprenden anticuerpos humanos frente a pcsk9.
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
PL4252857T3 (pl) 2011-09-16 2025-03-03 Regeneron Pharmaceuticals, Inc. Sposoby redukowania poziomów lipoproteiny(a) poprzez podawanie inhibitora proproteinowej konwertazy subtylizyny keksyny-9 (pcsk9)
US9255154B2 (en) 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
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
US10058630B2 (en) 2012-10-22 2018-08-28 Concievalve, Llc 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)
CA2914721A1 (en) 2013-06-07 2014-12-11 Regeneron Pharmaceuticals, Inc. Methods for inhibiting atherosclerosis by administering an inhibitor of pcsk9
JP6616298B2 (ja) 2013-11-12 2019-12-04 サノフィ・バイオテクノロジー Ｐｃｓｋ９阻害剤と共に使用するための投薬レジメン
AU2015258859B2 (en) 2014-05-15 2020-07-23 Rani Therapeutics, Llc Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
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
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
WO2016010927A1 (en) * 2014-07-14 2016-01-21 Amgen Inc. Crystalline antibody formulations
CA2955294A1 (en) 2014-07-16 2016-01-21 Sanofi Biotechnology Methods for treating patients with heterozygous familial hypercholesterolemia (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
AU2016320867B2 (en) * 2015-09-08 2023-03-30 Rani Therapeutics, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US10939164B2 (en) 2016-05-10 2021-03-02 Rovi Guides, Inc. Method and system for transferring an interactive feature to another device
US20190321515A1 (en) * 2016-06-27 2019-10-24 ConcieValve LLC Improved methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
CA3058567A1 (en) 2017-04-13 2018-10-18 Cadila Healthcare Limited Novel peptide based pcsk9 vaccine
GB201720162D0 (en) 2017-12-04 2018-01-17 Univ Oxford Innovation Ltd Method
CR20210441A (es) 2019-01-18 2022-03-11 Astrazeneca Ab Inhibidores de la pcsk9 y métodos de uso de los mismos

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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)

Family Cites Families (5)

* 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).
MX347602B (es) * 2011-01-28 2017-05-03 Sanofi Biotechnology Composiciones farmaceuticas que comprenden anticuerpos humanos frente a pcsk9.
US9255154B2 (en) * 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
CN107243078A (zh) * 2012-05-25 2017-10-13 克塔巴西斯制药有限公司 使前蛋白转化酶枯草溶菌素/kexin 9型（pcsk9）减少的方法

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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)

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
EVAN A.STEIN等: "Effect of a monoclonal antibody to PCSK9 on LDL cholesterol", 《NEW ENGLAND JOURNAL OF MEDICINE》 *
JAMES M. MCKENNEY等: "Safety and Efficacy of a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease, SAR236553/REGN727, in Patients With Primary Hypercholesterolemia Receiving Ongoing Stable Atorvastatin Therapy", 《JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY》 *

Also Published As

Publication number Publication date
WO2015123423A3 (en) 2015-10-08
MX2016010504A (es) 2016-12-09
WO2015123423A2 (en) 2015-08-20
KR20160115939A (ko) 2016-10-06
AU2015217118A1 (en) 2016-08-18
US20150231236A1 (en) 2015-08-20
JP2017506626A (ja) 2017-03-09
CA2939507A1 (en) 2015-08-20
EA201691320A1 (ru) 2016-11-30
US20180296672A1 (en) 2018-10-18
EP3104879A2 (en) 2016-12-21

Similar Documents

Publication Publication Date Title
CN106029096A (zh) 用于治疗具有未被中等剂量他汀疗法充分控制的高胆固醇血症的患者的方法
JP2022141868A (ja) 心血管リスクを低減させる方法
US20200216565A1 (en) METHODS FOR TREATING PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (heFH) WITH AN ANTI-PCSK9 ANTIBODY
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
US20200024364A1 (en) Dosing regimens for use with pcsk9 inhibitors
CN107922507B (zh) 抗pcsk9抑制性抗体用来治疗接受脂蛋白单采的高脂血症患者
CN105814085A (zh) Pcsk9抑制剂用于治疗高血脂症的用途
CN109069868B (zh) 通过施用与angptl3抑制剂组合的pcsk9抑制剂治疗高脂血症患者的方法
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
EA041556B1 (ru) Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией подвергающихся аферезу липопротеинов
HK40059806A (en) Dosing regimens for use with pcsk9 inhibitors
HK1232890A1 (en) Methods for reducing cardiovascular risk
HK1232890B (en) Methods for reducing cardiovascular risk

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20161012

WD01 Invention patent application deemed withdrawn after publication