CAMZYOS (mavacamten)
青少年症狀性梗阻性肥厚型心肌病 · 12 歲至未滿 18 歲的症狀性梗阻性肥厚型心肌病青少年
BMY · BMYBristol-Myers Squibb Company
監管認定
完整時間線
5 個里程碑預計 FDA 作出決定
FDA 將 CAMZYOS 用於症狀性梗阻性肥厚型心肌病青少年的 sNDA PDUFA 日期定為 2026 年 9 月 30 日。
Bristol Myers Squibb — sNDA acceptance and PDUFA date↗FDA 受理 sNDA 並授予優先審評
FDA 依據 3 期 SCOUT-HCM 試驗受理申請，並授予優先審評。
Bristol Myers Squibb — sNDA acceptance and Priority Review↗SCOUT-HCM 詳細結果公佈並發表
在 44 名患者的試驗中，CAMZYOS 使 Valsalva 左心室流出道壓差獲得具有臨床意義且統計學顯著的下降，未發現新的安全性信號。
Bristol Myers Squibb — Detailed Phase 3 SCOUT-HCM results↗SCOUT-HCM 公佈積極頂線結果
該 3 期試驗達到主要終點和多項次要終點，安全性結果與已確立的成人特徵一致。
Bristol Myers Squibb — Positive SCOUT-HCM topline results↗相關新聞
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