欧洲药品管理局:授予MB-107慢病毒基因疗法治疗X连锁严重综合免疫缺陷病的先进疗法分类

2020-04-21 Allan MedSci原创

Mustang是一家临床阶段的生物制药公司,致力于使用细胞和基因疗法治疗血液学肿瘤、实体瘤和罕见遗传病。

Mustang是一家临床阶段的生物制药公司,致力于使用细胞和基因疗法治疗血液学肿瘤、实体瘤和罕见遗传病。近日,欧洲药品管理局(EMA)已授予MB-107先进疗法分类(ATMP),用于治疗X连锁严重综合免疫缺陷病(XSCID)。美国FDA先前于2019年8月授予MB-107再生医学高级疗法(RMAT)称号,用于治疗XSCID。

ATMP为MB-107的临床前开发、制造和产品质量测试提供了特定的监管指南,并提供了激励措施,包括降低质量和非临床数据评估和认证的费用。

Mustang总裁兼首席执行官Manuel Litchman博士说:“我们非常高兴EMA授予MB-107先进疗法分类,这是Mustang在欧洲建立市场认可的重要一步。X连锁严重综合免疫缺陷病患者迫切需要创新且可能具有治愈性的治疗选择”。

 

原始出处:

https://www.firstwordpharma.com/node/1716765

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    2020-04-23 ymljack
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