伊米苷酶生物类似药(ISU Abxis Co., Ltd.)(Imiglucerase biosimilar(ISU Abxis Co., Ltd.)) - 药物靶点：GBA1_在研适应症：戈谢病_专利_临床

概要

基本信息

药物类型

生物类似药、酶

别名

Abcertin、Imiglucerase Biosimilar (ISU Abxis Co., Ltd.)、伊米苷酶生物类似药（ISU Abxis Co., Ltd.）

+ [2]

靶点

GBA1

作用方式

刺激剂

作用机制

GBA刺激剂(β-葡糖脑苷脂酶刺激剂)

治疗领域

神经系统疾病遗传病与畸形内分泌与代谢疾病+ [1]

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段批准上市

首次获批日期

韩国 (2012-10-09),

戈谢病

最高研发阶段(中国)-

特殊审评孤儿药 (韩国)

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结构/序列

Sequence Code 9157632

当前序列信息引自: *****

关联

5

项与伊米苷酶生物类似药(ISU Abxis Co., Ltd.) 相关的临床试验

ACTRN12619001399189

/ Completed临床1期

A randomized, double-blind, 2-treatment, 2-period, crossover phase I study to compare the pharmacokinetics, safety and tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme® in healthy volunteers following a single intravenous administration.

开始日期2020-02-07

申办/合作机构

ISU Abxis Co., Ltd.

NCT04787887

/ Completed临床1期

A Randomized, Double-blind, 2-treatment, 2-period, Crossover Phase I Study to Compare the PK, Safety and Tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme® in Healthy Volunteers Following a Single Intravenous Administration

Primary Objective:
To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.
Secondary Objective:
To compare the safety, tolerability and immunogenicity of Abcertin to the reference formulation, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.

开始日期2020-01-29

申办/合作机构

ISU Abxis Co., Ltd.

NCT02770625

/ Completed临床3期

A Multicenter, Open-Label Phase III Study to Evaluate the Safety and Efficacy of ISU302 (Imiglucerase for Injection) in Patients With Type 1 Gaucher Disease

The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with Type 1 Gaucher disease.

开始日期2011-09-01

申办/合作机构

ISU Abxis Co., Ltd.

100 项与伊米苷酶生物类似药(ISU Abxis Co., Ltd.) 相关的临床结果

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100 项与伊米苷酶生物类似药(ISU Abxis Co., Ltd.) 相关的转化医学

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100 项与伊米苷酶生物类似药(ISU Abxis Co., Ltd.) 相关的专利（医药）

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项与伊米苷酶生物类似药(ISU Abxis Co., Ltd.) 相关的文献（医药）

2022-02-01·Drug Safety2区 · 医学

Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database

2区 · 医学

Article

作者: Lewis, Grace ; Tsang, So-Fai ; Keutzer, Joan ; Barakov, Kristina ; Ross, Leorah ; Freisens, Selena ; Pandya, Shirali

INTRODUCTIONApproved in 1994 and assigned the International Nonproprietary Name (INN) imiglucerase by the World Health Organization, Cerezyme^® (Sanofi Genzyme) is an enzyme replacement therapy used to treat Gaucher disease in > 90 countries. At least two therapies approved outside the USA and the European Union, Abcertin^® and Asbroder^®, have adopted the identical INN imiglucerase. Both drugs were approved via regulatory pathways not aligned with World Health Organization Similar Biotherapeutic Product guidelines.OBJECTIVEWe analyzed whether the use of the identical INN "imiglucerase" for these drugs impacts adverse event (AE) reporting in the Sanofi Global Safety Database.METHODSFirst, we reviewed all imiglucerase individual case safety reports (referred to as cases) including AE data reported between January 2012 and March 2018 that contained Abcertin or Asbroder in the narrative. In a second analysis, we examined cases from Mexico reported between May 2013 and March 2018 to assess changes in imiglucerase reporting following the 2015 approval of Asbroder in Mexico.RESULTSFifty-six cases mentioning Asbroder and none mentioning Abcertin were retrieved in the first analysis. Upon close review, the AEs of 45 cases (80.4%) were attributed to Asbroder, one (1.8%) to Cerezyme; the specific drug attribution for the AEs of ten cases (17.9%) could not be determined. In the second analysis, a substantial increase in cases and AEs was observed in the period after Asbroder approval (73 cases with 150 AEs pre-approval vs 132 cases with 333 AEs post-approval). Twenty-three of 132 (17.4%) post-approval cases reported discontinuation of treatment (19 related to Asbroder AEs, and four related to Cerezyme AEs). Infusion-associated reactions occurred in 25/132 cases (17 Asbroder related, six Cerezyme related, two indeterminate).CONCLUSIONSThis analysis demonstrates two potential consequences of identical INN use between Cerezyme and Asbroder: (1) an aggregate safety profile for Cerezyme that includes other products using the identical INN leading to inaccurate pharmacovigilance data and (2) healthcare providers switching, substituting, or potentially assuming interchangeability between the products. Identical INN use without the brand name differentiator may compromise pharmacovigilance data, potentially masking differences in safety profiles between products.

2018-08-01·Medicine4区 · 医学

Erratum

4区 · 医学

ArticleOA

2017-11-01·Medicine

A multicenter, open-label, phase III study of Abcertin in Gaucher disease

Article

作者: Mahmoud, Mona Mohamed Hamdy ; Eid, Khaled Mohamed Abd El-Azim ; Heo, Sun Hee ; Megahed, Ahmed Megahed Hassan ; Elsayed, Mona Abdel Latif ; Fateen, Ekram ; Kim, Gu-Hwan ; Lee, Beom Hee ; Choi, Jin-Ho ; Abdalla, Ahmed Fathy ; Beshlawy, Amal El ; Yoo, Han-Wook ; Barakat, Tarik El-Sayed Mohammad ; Park, June-Young ; El-Tagui, Mona Hassan

BACKGROUNDGaucher disease (GD) is caused by a deficiency in the lysosomal enzyme glucocerebrosidase. Enzyme replacement therapy (ERT) is recommended for clinical improvement.METHODSThe efficacy and safety of a new imiglucerase, Abcertin, were assessed in 7 Egyptian patients with treatment-naïve type 1 GD. Each patient was administered a biweekly 60 U/kg dose of Abcertin for 6 months. The primary endpoint was the change in hemoglobin concentration. The secondary endpoints were changes from baseline in platelet counts, spleen and liver volumes, biomarker levels, skeletal parameters, and bone mineral density.RESULTSThe hemoglobin concentration increased by a mean of 1.96 ± 0.91 g/dL (range 1.11-2.80 g/dL) or 20.6% (P = .001). Statistically significant increases in the platelet count and decreases in the spleen volume and biomarker levels were also observed. There were no severe drug-related adverse events. One patient developed anti-imiglucerase antibodies without neutralizing activity.CONCLUSIONOur study results demonstrate the efficacy and safety of Abcertin in patients with type 1 GD. This suggests that Abcertin can be an alternative ERT option for type 1 GD.

100 项与伊米苷酶生物类似药(ISU Abxis Co., Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A16AB02	DB00053

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
戈谢病	韩国	ISU Abxis Co., Ltd.	2012-10-09

未上市

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适应症	最高研发状态	国家/地区	公司	日期
戈谢病	临床3期	澳大利亚	ISU Abxis Co., Ltd.	2020-01-29
I型戈谢病	临床3期	-	ISU Abxis Co., Ltd.	2011-09-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02770625 (CTgov)	临床3期	I型戈谢病	8	ISU302	艱壓遞觸鏇選網襯製觸(範齋觸齋壓憲齋鏇鹹簾) = 醖窪鹽醖鑰窪獵憲壓築艱壓觸顧製願鹽鑰鹽膚 (願窪觸齋鏇網鬱鏇構艱, 構顧製遞範鑰獵醖淵淵 ~ 廠醖淵鏇蓋鑰衊觸簾膚) 更多	-	2017-07-12