FDA授予Andromeda公司糖尿病药物DiaPep277孤儿药地位

2012-05-31 jewell 生物谷

5月28日,巴勒斯坦生物技术公司Andromeda宣布,FDA已授予DiaPep277孤儿药地位,用于治疗有残余β细胞功能的1型糖尿病(T1D)患者。 DiaPep277是源自人热休克蛋白60(HSP60)序列上的一段含24个氨基酸的肽段,它能够调节免疫系统,使胰岛细胞免受破坏并保护胰岛素分泌功能。 FDA授予的孤儿药地位使其享有七年的独家销售权,以及诸如减税、降低用户费用及注册快速通道等便利

5月28日,巴勒斯坦生物技术公司Andromeda宣布,FDA已授予DiaPep277孤儿药地位,用于治疗有残余β细胞功能的1型糖尿病(T1D)患者。

DiaPep277是源自人热休克蛋白60(HSP60)序列上的一段含24个氨基酸的肽段,它能够调节免疫系统,使胰岛细胞免受破坏并保护胰岛素分泌功能。

FDA授予的孤儿药地位使其享有七年的独家销售权,以及诸如减税、降低用户费用及注册快速通道等便利。

DiaPep277正在进行III期临床试验。一项早期试验已达到其主要疗效指标。现在关于DiaPep277的全球性III期试验正在120多个医疗中心进行。

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    2012-10-12 feather89
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