CAMZYOS (mavacamten)
青少年症状性梗阻性肥厚型心肌病 · 12 岁至未满 18 岁的症状性梗阻性肥厚型心肌病青少年
BMY · BMYBristol-Myers Squibb Company
监管认定
完整时间线
5 个里程碑预计 FDA 作出决定
FDA 将 CAMZYOS 用于症状性梗阻性肥厚型心肌病青少年的 sNDA PDUFA 日期定为 2026 年 9 月 30 日。
Bristol Myers Squibb — sNDA acceptance and PDUFA date↗FDA 受理 sNDA 并授予优先审评
FDA 依据 3 期 SCOUT-HCM 试验受理申请，并授予优先审评。
Bristol Myers Squibb — sNDA acceptance and Priority Review↗SCOUT-HCM 详细结果公布并发表
在 44 名患者的试验中，CAMZYOS 使 Valsalva 左心室流出道压差获得具有临床意义且统计学显著的下降，未发现新的安全性信号。
Bristol Myers Squibb — Detailed Phase 3 SCOUT-HCM results↗SCOUT-HCM 公布积极顶线结果
该 3 期试验达到主要终点和多项次要终点，安全性结果与已确立的成人特征一致。
Bristol Myers Squibb — Positive SCOUT-HCM topline results↗相关新闻
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