JP2023506732A - ホモ接合型家族性高コレステロール血症を処置するためのpcsk9阻害剤の使用 - Google Patents

ホモ接合型家族性高コレステロール血症を処置するためのpcsk9阻害剤の使用 Download PDF

Info

Publication number
JP2023506732A
JP2023506732A JP2022535060A JP2022535060A JP2023506732A JP 2023506732 A JP2023506732 A JP 2023506732A JP 2022535060 A JP2022535060 A JP 2022535060A JP 2022535060 A JP2022535060 A JP 2022535060A JP 2023506732 A JP2023506732 A JP 2023506732A
Authority
JP
Japan
Prior art keywords
patient
antibody
patients
pcsk9
hofh
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.)
Ceased
Application number
JP2022535060A
Other languages
English (en)
Japanese (ja)
Other versions
JP2023506732A5 (cg-RX-API-DMAC7.html
Inventor
シャジア・アリ
マリー・バカラ-ディネ
ステファン・ドナヒュー
コリンヌ・アノタン
ギヨーム・ルコル
ロバート・シー・ポーディー
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 JP2023506732A publication Critical patent/JP2023506732A/ja
Publication of JP2023506732A5 publication Critical patent/JP2023506732A5/ja
Ceased legal-status Critical Current

Links

Images

Classifications

    • 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
    • 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
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/002—Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic with sealing means to be broken or opened
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • 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
    • A61P9/06—Antiarrhythmics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], 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
    • A61K2039/54—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
    • 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
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2022535060A 2019-12-10 2020-12-10 ホモ接合型家族性高コレステロール血症を処置するためのpcsk9阻害剤の使用 Ceased JP2023506732A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962946268P 2019-12-10 2019-12-10
US62/946,268 2019-12-10
US202062987148P 2020-03-09 2020-03-09
US62/987,148 2020-03-09
PCT/US2020/064324 WO2021119321A1 (en) 2019-12-10 2020-12-10 Use of a pcsk9 inhibitor to treat homozygous familial hypercholesterolemia

Publications (2)

Publication Number Publication Date
JP2023506732A true JP2023506732A (ja) 2023-02-20
JP2023506732A5 JP2023506732A5 (cg-RX-API-DMAC7.html) 2023-12-18

Family

ID=74175938

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2022535060A Ceased JP2023506732A (ja) 2019-12-10 2020-12-10 ホモ接合型家族性高コレステロール血症を処置するためのpcsk9阻害剤の使用

Country Status (10)

Country Link
US (1) US20230272112A1 (cg-RX-API-DMAC7.html)
EP (1) EP4072672A1 (cg-RX-API-DMAC7.html)
JP (1) JP2023506732A (cg-RX-API-DMAC7.html)
KR (1) KR20220125249A (cg-RX-API-DMAC7.html)
CN (1) CN115066272A (cg-RX-API-DMAC7.html)
AU (1) AU2020402044A1 (cg-RX-API-DMAC7.html)
CA (1) CA3161347A1 (cg-RX-API-DMAC7.html)
IL (1) IL293617A (cg-RX-API-DMAC7.html)
MX (1) MX2022007071A (cg-RX-API-DMAC7.html)
WO (1) WO2021119321A1 (cg-RX-API-DMAC7.html)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020150473A2 (en) 2019-01-18 2020-07-23 Dogma Therapeutics, Inc. Pcsk9 inhibitors and methods of use thereof
BR112021013924A2 (pt) 2019-01-18 2021-09-21 Astrazeneca Ab Inibidores de pcsk9 e métodos de uso do mesmo

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019506423A (ja) * 2016-02-26 2019-03-07 ジェンファイア・セラピューティクス・インコーポレイテッドGemphire Therapeutics Inc. 脂質低下療法を受けているホモ接合性家族性高コレステロール血症患者の治療

Family Cites Families (10)

* 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).
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
ES2773111T3 (es) * 2011-09-16 2020-07-09 Regeneron Pharma Inhibidor de la proproteína convertasa subtilisina/kexina 9 (PCSK9) para su uso en la reducción de los niveles de lipoproteína (a)
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)
TWI682780B (zh) * 2013-05-30 2020-01-21 美商再生元醫藥公司 醫藥組成物用於製造治療與pcsk9功能獲得性突變有關之體染色體顯性高膽固醇血症的藥物之用途
US20150004174A1 (en) * 2013-06-28 2015-01-01 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
MX373298B (es) * 2013-10-11 2020-05-20 Sanofi Biotechnology Uso de un inhibidor de pcsk9 para tratar la hiperlipidemia.
KR20230074283A (ko) 2014-07-16 2023-05-26 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
PT3689913T (pt) * 2014-10-09 2022-06-20 Regeneron Pharma Uso de um inibidor de pcsk9 para tratar a hiperlipidemia

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019506423A (ja) * 2016-02-26 2019-03-07 ジェンファイア・セラピューティクス・インコーポレイテッドGemphire Therapeutics Inc. 脂質低下療法を受けているホモ接合性家族性高コレステロール血症患者の治療

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
J. CLIN. LIPIDOL., vol. 12, JPN6024043395, 2018, pages 390 - 396, ISSN: 0005625217 *

Also Published As

Publication number Publication date
IL293617A (en) 2022-08-01
CN115066272A (zh) 2022-09-16
CA3161347A1 (en) 2021-06-17
US20230272112A1 (en) 2023-08-31
AU2020402044A1 (en) 2022-07-28
KR20220125249A (ko) 2022-09-14
EP4072672A1 (en) 2022-10-19
MX2022007071A (es) 2022-07-11
WO2021119321A1 (en) 2021-06-17

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
JP2022141868A (ja) 心血管リスクを低減させる方法
JP7744190B2 (ja) リポタンパク質アフェレーシスを受けている高脂血症の患者を治療するための抗pcsk9阻害抗体
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
JP6616298B2 (ja) Pcsk9阻害剤と共に使用するための投薬レジメン
KR20200129127A (ko) 심혈관 위험을 감소시키기 위한 pcsk9 억제제의 용도
JP2019513751A (ja) Angptl8阻害剤およびangptl3阻害剤を用いて高脂血症を処置するための方法
TW201536315A (zh) 治療與pcsk9功能獲得性突變有關之體染色體顯性高膽固醇血症之方法
JP2022078306A (ja) Angptl3阻害剤と組み合わせてpcsk9阻害剤を投与することにより高脂血症を有する患者を処置するための方法
JP2017522316A (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
JP2016520616A (ja) プロタンパク質変換酵素スブチリシンケキシン−9(pcsk9)の阻害剤を投与することによるレムナントコレステロールおよび他のリポタンパク質画分を減少させるための方法
US20230272112A1 (en) Use of a pcsk9 inhibitor to treat homozygous familial hypercholesterolemia
JP2020143156A (ja) 心血管リスクを低減させる方法
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
JP2020037566A (ja) Pcsk9阻害剤と共に使用するための投薬レジメン
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: 20231208

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20231208

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20241029

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20241030

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20250129

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250326

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20250624

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251016

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20260113

A045 Written measure of dismissal of application [lapsed due to lack of payment]

Free format text: JAPANESE INTERMEDIATE CODE: A045

Effective date: 20260526