Jyseleca(filgotinib)治疗类风湿性关节炎:已获得日本和欧盟的批准

2020-09-26 Allan MedSci原创

吉利德科学公司本周五宣布,欧盟委员会已批准Jyseleca(filgotinib)治疗中度至重度活动性类风湿性关节炎(RA)的成年患者。

类风湿性关节炎(rheumatic arthritis,RA)是一种常见的急性或慢性结缔组织炎症。它通常导致关节发热、肿胀和疼痛。最常见的是手腕和手涉及到身体两侧相同的关节。这个疾病也可能影响身体其他部分。这可能导致低红血球细胞、肺部炎症、和心脏炎症。也可能会发烧和缺乏活力。通常症状是逐渐超过数周至数月。

吉利德科学公司本周五宣布,欧盟委员会已批准Jyseleca(filgotinib)治疗中度至重度活动性类风湿性关节炎(RA)的成年患者,这些成年患者对一种或多种治疗没有足够的反应。该公司当天早些时候表示,日本监管机构已批准Jyseleca治疗常规疗法反应不足的RA患者。Jyseleca(filgotinib)是吉利德正在开发的每日一次的口服型JAK1抑制剂。

这两项批准均基于III期FINCH和II期DARWIN研究的最新结果,这些研究结果表明,接受Jyseleca(filgotinib)的患者的临床症状和体征有所改善,且疾病活动有所减少。

在日本,吉利德(Gilead)将负责Jyseleca的供应,而卫材(Eisai)将负责产品分销。

 

原始出处:

https://www.firstwordpharma.com/node/1760426?tsid=4

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    2020-09-28 lmm397
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