JP2024515555A - L-アスパラギナーゼの製剤 - Google Patents

L-アスパラギナーゼの製剤 Download PDF

Info

Publication number
JP2024515555A
JP2024515555A JP2023561628A JP2023561628A JP2024515555A JP 2024515555 A JP2024515555 A JP 2024515555A JP 2023561628 A JP2023561628 A JP 2023561628A JP 2023561628 A JP2023561628 A JP 2023561628A JP 2024515555 A JP2024515555 A JP 2024515555A
Authority
JP
Japan
Prior art keywords
formulation
asparaginase
administered
amount
present disclosure
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
JP2023561628A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024515555A5 (cg-RX-API-DMAC10.html
Inventor
セカール カナプラン
ハリパダ マイティ
グイフェン ジャン
ロジャ ナーワル
Original Assignee
ジャズ ファーマシューティカルズ アイルランド リミテッド
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 ジャズ ファーマシューティカルズ アイルランド リミテッド filed Critical ジャズ ファーマシューティカルズ アイルランド リミテッド
Publication of JP2024515555A publication Critical patent/JP2024515555A/ja
Publication of JP2024515555A5 publication Critical patent/JP2024515555A5/ja
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/50—Hydrolases (3) acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y305/00—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5)
    • C12Y305/01—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5) in linear amides (3.5.1)
    • C12Y305/01001—Asparaginase (3.5.1.1)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Wood Science & Technology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Enzymes And Modification Thereof (AREA)
JP2023561628A 2021-04-06 2022-04-05 L-アスパラギナーゼの製剤 Pending JP2024515555A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163171429P 2021-04-06 2021-04-06
US63/171,429 2021-04-06
PCT/US2022/071562 WO2022217231A1 (en) 2021-04-06 2022-04-05 Formulations of l-asparaginase

Publications (2)

Publication Number Publication Date
JP2024515555A true JP2024515555A (ja) 2024-04-10
JP2024515555A5 JP2024515555A5 (cg-RX-API-DMAC10.html) 2025-04-14

Family

ID=81748398

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023561628A Pending JP2024515555A (ja) 2021-04-06 2022-04-05 L-アスパラギナーゼの製剤

Country Status (12)

Country Link
EP (1) EP4319818A1 (cg-RX-API-DMAC10.html)
JP (1) JP2024515555A (cg-RX-API-DMAC10.html)
KR (1) KR20230165799A (cg-RX-API-DMAC10.html)
CN (1) CN117377494A (cg-RX-API-DMAC10.html)
AR (1) AR125301A1 (cg-RX-API-DMAC10.html)
AU (1) AU2022256071A1 (cg-RX-API-DMAC10.html)
BR (1) BR112023019862A2 (cg-RX-API-DMAC10.html)
CA (1) CA3213726A1 (cg-RX-API-DMAC10.html)
CL (1) CL2023002983A1 (cg-RX-API-DMAC10.html)
CO (1) CO2023014093A2 (cg-RX-API-DMAC10.html)
MX (1) MX2023011693A (cg-RX-API-DMAC10.html)
WO (1) WO2022217231A1 (cg-RX-API-DMAC10.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022211829A1 (en) * 2021-03-30 2022-10-06 Jazz Pharmaceuticals Ireland Ltd. Dosing of recombinant l-asparaginase

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019521179A (ja) * 2016-06-01 2019-07-25 セルヴィエ アイピー ユーケー リミテッド ポリアルキレンオキシド−アスパラギナーゼの製剤ならびにその製造法および使用法
JP2021505661A (ja) * 2017-11-30 2021-02-18 ジャズ ファーマシューティカルズ アイルランド リミテッド アスパラギナーゼを用いた治療法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007103290A2 (en) 2006-03-03 2007-09-13 Government Of The United States Of America, Represented By The Secretary, Department Of Health And Human Services Materials and methods directed to asparagine synthetase and asparaginase therapies
CA3156066A1 (en) * 2019-10-25 2021-04-29 Mi Rim Choi Recombinant l-asparaginase

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019521179A (ja) * 2016-06-01 2019-07-25 セルヴィエ アイピー ユーケー リミテッド ポリアルキレンオキシド−アスパラギナーゼの製剤ならびにその製造法および使用法
JP2021505661A (ja) * 2017-11-30 2021-02-18 ジャズ ファーマシューティカルズ アイルランド リミテッド アスパラギナーゼを用いた治療法

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
JOURNAL OF MOLECULAR CATALYSIS B: ENZYMATIC, vol. 122, JPN6026007738, 28 August 2015 (2015-08-28), pages 8 - 14, ISSN: 0005806014 *
PROCESS BIOCHEMISTRY, vol. 81, JPN6026007737, 11 March 2019 (2019-03-11), pages 123 - 131, ISSN: 0005806013 *
薬剤学, vol. vol. 74(1), JPN6026007739, 2014, pages 12 - 18, ISSN: 0005806015 *

Also Published As

Publication number Publication date
KR20230165799A (ko) 2023-12-05
AU2022256071A1 (en) 2023-10-19
MX2023011693A (es) 2023-12-15
EP4319818A1 (en) 2024-02-14
WO2022217231A1 (en) 2022-10-13
CN117377494A (zh) 2024-01-09
BR112023019862A2 (pt) 2023-11-07
AR125301A1 (es) 2023-07-05
CO2023014093A2 (es) 2023-10-30
CA3213726A1 (en) 2022-10-13
CL2023002983A1 (es) 2024-04-12

Similar Documents

Publication Publication Date Title
USRE49736E1 (en) Pegylated L-asparaginase
CN111818937A (zh) 使用天冬酰胺酶的治疗方法
JP2022526799A5 (cg-RX-API-DMAC10.html)
US12564619B2 (en) Stable formulations of recombinant proteins
AU2022256071A1 (en) Formulations of l-asparaginase
JP2022527322A (ja) Fms様チロシンキナーゼ3リガンド(flt3l)ベースキメラタンパク質
US11554156B2 (en) Pharmaceutical formulations of C1 esterase inhibitor
US20240197841A1 (en) Formulations of l-asparaginase
JP2016526533A (ja) アミリンミメティック化合物とポリエチレングリコールの非凝集バイオ接合体
US20180036394A1 (en) Pharmaceutical formulations of c1 esterase inhibitor
US12551540B2 (en) Dosing and administration of recombinant L-asparaginase
US20250215086A1 (en) Anti-pd-1 antibody formulations
KR20250004790A (ko) 항-her2 항체를 함유하는 피하 투여용 약학 조성물
JPWO2000049041A1 (ja) 蛋白質製剤
EP2606908A1 (en) Novel pharmaceutical composition for a long acting growth hormone fusion protein (LAGH)

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250404

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20250404

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20260227

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20260302

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20260529

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20260709

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20260713

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20260722

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20260709