Scholar Rock Holding Corp宣布，其针对面肩肱型肌营养不良症（FSHD）的在研药物Apitegromab已获得美国食品药品监督管理局（FDA）的快速通道认定。与此同时，该药物的二期FORGE试验已正式启动受试者给药。
这一里程碑式的进展标志着Scholar Rock在攻克这一罕见神经肌肉疾病方面迈出了关键一步。快速通道资格旨在加速针对严重疾病且存在未满足医疗需求的新药研发与审评进程，有望为患者带来更早的治疗希望。
值得注意的是，FSHD是一种进行性加重的肌肉萎缩疾病，目前临床上缺乏有效的治疗手段。Apitegromab作为一种潜在的首创疗法，其研发进展备受业界关注。随着二期试验的受试者开始接受治疗，研究者将有望获得更多关于该药物安全性及有效性的关键数据。
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