Intercept向美国FDA提交奥贝胆酸治疗NASH的新药申请

2019-09-29 Allan MedSci原创

Intercept Pharmaceuticals是一家专注于治疗进行性非病毒性肝病的生物制药公司,近日宣布,已向美国FDA提交了奥贝胆酸(OCA)治疗非酒精性脂肪性肝炎(NASH)所致的纤维化的新药申请(NDA)。

Intercept Pharmaceuticals是一家专注于治疗进行性非病毒性肝病的生物制药公司,近日宣布,已向美国FDA提交了奥贝胆酸(OCA)治疗非酒精性脂肪性肝炎(NASH)所致的纤维化的新药申请(NDA)。

OCAFDA指定的,治疗NASH纤维化的唯一疗法。因此,Intercept要求对NDA进行优先审核。该提交是基于关键性IIIREGENERATE研究的中期分析结果。在该研究中,OCA 25 mg使肝纤维化(≥1期)得到了显著改善,而在18个月时NASH没有恶化(相对于安慰剂,p = 0.0002),从而达到了其主要终点。


原始出处:

http://www.firstwordpharma.com/node/1670033#axzz60v7gfnQg

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    2019-10-01 kksonne
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