FDA授予SNF472治疗晚期肾脏疾病外周动脉疾病的“孤儿药称号”

2021-02-11 Allan MedSci原创

生物制药公司Sanifit今天宣布,美国食品药品监督管理局(FDA)授予其SNF472“孤儿药称号”(ODD)。

动脉粥样硬化是由于血管内膜和中膜层之间的脂质和纤维物质积累导致大、中动脉管腔局灶性或弥漫性狭窄的一种系统性疾病。非心脏血管的动脉粥样硬化被定义为外周动脉疾病(PAD)。

生物制药公司Sanifit今天宣布,美国食品药品监督管理局(FDA)授予其SNF472“孤儿药称号”(ODD),用于治疗晚期肾脏疾病(ESKD)患者的外周动脉疾病(PAD)。

Sanifit首席执行官JoanPerelló博士评论说:“美国FDA授予治疗ESKD PAD的孤儿药资格,是对该病患者的重视,它进一步验证了SNF472在该适应症中的潜力。在美国和欧洲,分别有大约175,000和150,000例PAD-ESKD患者,目前尚无有效的治疗方法,先前的临床试验也已排除了这些患者”。

SNF472是血管钙化的抑制剂,并且是临床试验中唯一的候选药物,其直接抑制固体钙(羟基磷灰石)在心血管系统中的沉积。PAD是一种通过减少流向四肢的血液而影响周围动脉的心血管疾病。 ESKD中的PAD具有很强的动脉钙化程度,这使其成为目前没有可用疗法的具有挑战性的疾病。据报道,在美国,ESKD慢性血液透析患者的PAD患病率高达38%,其他国家的患病率与美国相似。

 

原始出处:

https://www.firstwordpharma.com/node/1799632?tsid=4

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    2021-06-04 red咩

    学习一下

    0

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    2021-02-13 carrotlyl

    涨知识

    0

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