GRAZAX®: a sublingual immunotherapy vaccine for Hay fever treatment: from concept to commercialization

被引：11

作者：

Barber, Domingo ^{[1
]}

Rico, Pilar ^{[1
]}

Blanco, Carlos ^{[2
]}

Fernandez-Rivas, Montserrat ^{[3
]}

Dolores Ibanez, Maria ^{[4
]}

Escribese, Maria M. ^{[1
,5
]}

机构：

[1] Univ CEU San Pablo, Inst Appl Mol Med IMMA, Sch Med, Madrid, Spain

[2] Hosp Univ Princesa, Allergy Dept, Madrid, Spain

[3] Hosp Clin San Carlos, IdISSc, Allergy Dept, Madrid, Spain

[4] Hosp Infantil Univ Nino Jesus IIS La Princesa Fib, Allergy Dept, Madrid, Spain

[5] Univ CEU San Pablo, Dept Basic Med Sci, Sch Med, Madrid, Spain

来源：

HUMAN VACCINES & IMMUNOTHERAPEUTICS | 2019年 / 15卷 / 12期

关键词：

Grazax; allergen immunotherapy; allergy vaccine; sublingual immunotherapy; grass allergy; GRASS ALLERGEN TABLETS; QUALITY-OF-LIFE; TIMOTHY GRASS; IMMUNOLOGICAL CHANGES; CONTROLLED-TRIAL; DOUBLE-BLIND; SAFETY; EFFICACY; INITIATION; CHILDREN;

D O I：

10.1080/21645515.2019.1622976

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Allergen immunotherapy has been used for more than 100 y, but only recently underlying immunological mechanisms have started to be understood. New Allergy vaccines are now considered to be full pharmaceutical products, that should comply with general as well as specific pharmaceutical legal framework. GRAZAX (R) is the first global allergy vaccine developed in compliance with the new legal environment and is thus a reference for developing new allergy vaccines. Here, we provide a rationale description of GRAZAX (R), providing a sequential description of its pharmaceutical and clinical development. With more than 25 clinical trials, involving more than 8000 patients, including as well three 5-y prospective clinical trials, GRAZAX (R) is a key product to understand the unique position of allergen-specific immunotherapy as a disease-modifying intervention.

引用

页码：2887 / 2895

页数：9

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