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PLN-74809获得FDA孤儿药物认定用于治疗特发性肺纤维化

2018-08-07 MedSci MedSci原创

Pliant制药是一家专注于纤维化疾病治疗的生物技术公司,Pliant制药近日宣布美国食品和药物管理局(FDA)已授予该公司抗纤维化铅化合物PLN-74809的孤儿药资格,用于治疗特发性肺纤维化(IPF)。

Pliant制药是一家专注于纤维化疾病治疗的生物技术公司,Pliant制药近日宣布美国食品和药物管理局(FDA)已授予该公司抗纤维化铅化合物PLN-74809的孤儿药资格,用于治疗特发性肺纤维化(IPF)。IPF是一种慢性和进行性纤维化疾病,患者肺组织将变厚和僵硬,导致呼吸困难和生活质量下降。随着肺纤维化的进展,肺部越来越难以将氧气转移到血液中,最终阻止重要器官接收正常运作所必需的氧气。典型的IPF,主要表现为干咳、进行性呼吸困难,经数月或数年逐渐恶化,多在出现症状3-8年内进展至终末期呼吸衰竭或死亡。主要病理特点为肺间质和肺泡腔内纤维化和炎细胞浸润混合存在。在美国,IPF目前影响大约140,000人。

FDA的孤儿药物指定计划旨在激励和促进美国的罕见疾病(少于20万人)药物的开发。该指定将为Pliant提供各种商业激励措施,包括7年市场独占权和临床研究费用减免,以满足IPF患者的未被满足的医疗需求。Plian制药首席医疗官ÉricLefebvre博士说:“FDA孤儿药物资格认定为PLN-74809的研究性新药申请和首次人体试验提供了信心


原始出处:

http://www.firstwordpharma.com/node/1583297#axzz5NCMJrdAy

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    2018-08-10 太阳系小猪

    肺纤维化一直是研究的热点和难点~

    0

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