Scholar Rock重新向FDA提交Apitegromab治疗脊髓性肌萎缩症(SMA)的生物制剂许可申请(BLA)

美股速递
Mar 31

Scholar Rock Holding Corp(SRRK)已重新向美国食品药品监督管理局(FDA)提交了其候选药物Apitegromab的生物制剂许可申请(BLA),该药物旨在用于治疗儿童及成人脊髓性肌萎缩症(SMA)患者。

此次重新提交标志着该公司在推进这一潜在疗法监管审批过程中的又一重要步骤。脊髓性肌萎缩症是一种严重的遗传性神经肌肉疾病,Apitegromab作为一种研究性疗法,旨在改善患者的肌肉功能和运动能力。

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