FDA批准Reblozyl治疗骨髓增生异常综合症相关的贫血

2020-04-04 Allan MedSci原创

百时美施贵宝公司(Bristol Myers Squibb)近日宣布,FDA已扩大Reblozyl(luspatercept-aamt)的适应症范围。

百时美施贵宝公司(Bristol Myers Squibb)近日宣布,FDA已扩大Reblozyl(luspatercept-aamt)的适应症范围,允许Reblozyl治疗低风险骨髓增生异常综合症(MDS)相关的贫血。百时美施贵宝公司通过收购Celgene获得了红细胞成熟剂Reblozyl(luspatercept-aamt)的开发和销售权,Reblozyl曾于2019年11月获得FDA批准,用于治疗需要定期输注红细胞(RBC)的β地中海贫血。

FDA的此项批准是基于2020年1月份发表在NEJM上的关键性III期MEDALIST试验的结果。试验结果显示,与安慰剂相比,Reblozyl组的患者在至少八周内达到了研究的主要终点。Reblozyl(luspatercept-aamt)是一种可溶性融合蛋白,由人IgG1的Fc结构域与激活素IIB型受体(ActRIIB)胞外结构域融合而成,作为一种配体陷阱,通过靶向结合可调节晚期RBC成熟的转化生长因子(TGF)-β超家族的特定配体,减少Smad2/3信号通路的激活,改善无效红细胞的生成。

 

原始出处:

https://www.firstwordpharma.com/node/1713223

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    2020-09-25 bugit
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    2020-04-06 amy0557

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