Principia 制药宣布PRN1008获得FDA孤儿药认定用于治疗免疫性血小板减少性紫癜

2018-10-21 MedSci MedSci原创

Principia制药公司今天宣布,口服型可逆的共价Bruton酪氨酸激酶(BTK)抑制剂PRN1008已获美国食品和药物管理局(FDA)的孤儿药认定用于治疗免疫性血小板减少性紫癜(ITP)患者。

Principia制药公司今天宣布,口服型可逆的共价Bruton酪氨酸激酶(BTK)抑制剂PRN1008已获美国食品和药物管理局(FDA)的孤儿药认定用于治疗免疫性血小板减少性紫癜(ITP)患者。Principia目前正在进行一项II临床试验,以评估PRN1008ITP患者中的安全性和有效性。Principia先前于20176月获得FDA颁发的PRN1008的孤儿药物认定用于治疗寻常型疱疮。

Principia首席执行官Martin Babler说:我们将继续为有需要的ITP患者开发PRN1008FDA批准孤儿药认定是一个重要的里程碑。我们相信PRN1008有可能调节免疫系统对血小板的攻击,这是ITP的根本原因,并且是一种有效的口服疗法,同时可以减少侵入性免疫抑制剂的不良反应FDA的孤儿药指定计划旨在鼓励开发治疗罕见疾病或病症的产品,罕见病人群通常被定义为在美国少于200,000人的患者群体。作为获得孤儿药认定资格的制药企业可以获得7年的营销专营权及临床研究费用的税收抵免等。


原始出处:

http://www.firstwordpharma.com/node/1598620#axzz5UXJIsme7

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  5. 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08:03:03 CST 2018, time=2018-10-22, status=1, ipAttribution=)]
    2018-11-01 1e145228m78(暂无匿称)

    学习了,谢谢作者分享!

    0

  6. 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  8. 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  9. 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    2018-10-22 orangesking

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