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FDA接受BMS在梗阻性肥厚性心肌病(oHCM)中使用Mavacamten的申请

2021-03-21 Allan MedSci原创

制药公司BMS近日宣布,美国食品药品监督管理局(FDA)已接受其Mavacamten的新药申请(NDA),Mavacamten是一种针对症状性梗阻性肥厚性心肌病(oHCM)的肌球蛋白抑制剂。

制药公司BMS近日宣布,美国食品药品监督管理局(FDA)已接受其Mavacamten的新药申请(NDA),Mavacamten是一种针对症状性梗阻性肥厚性心肌病(oHCM)的肌球蛋白抑制剂。

肥厚性心肌病(HCM)是一种先天性或获得性疾病,以显著的心室肥厚伴舒张功能障碍为特点,但没有后负荷增加(如主动脉瓣狭窄、主动脉缩窄,全身性高血压)。症状包括胸痛,呼吸困难,晕厥以及猝死。

BMS血管发展高级副总裁Roland Chen医师说:“HCM是最常见的遗传性心脏病,患者可能会出现呼吸急促、头晕和疲劳以及严重的并发症,包括心力衰竭、心律不齐和心源性猝死。mavacamten是开发用于解决该疾病的一款肌球蛋白抑制剂。我们致力于为HCM患者提供支持,并期待与FDA合作”。

这项批准是基于关键的III期EXPLORER-HCM试验的结果。该试验的结果表明,mavacamten具有很强的治疗效果,在症状、功能状态和生活质量以及减轻左心室流出道梗阻的能力方面均有效。在EXPLORER-HCM研究中,达到了所有主要和次要终点。

Mavacamten是心脏肌球蛋白的变构调节剂。Mavacamten被认为可以通过抑制过度的肌球蛋白-肌动蛋白过桥形成来降低心肌收缩力。在临床和临床前研究中,mavacamten持续降低了心脏壁应力的生物标志物,减轻了过度的心脏收缩力,并增加了舒张期依从性。

 

原始出处:

https://www.firstwordpharma.com/node/1811186?tsid=4

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    2021-10-13 whmdzju
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    2021-07-29 lishizhe
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    2021-03-23 病毒猎手

    这是划时代药物!!

    0

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    2021-03-23 canlab
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    2021-03-23 仁者大医
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