FDA授予Hympavzi®(Marstacimab)优先审评资格,用于治疗存在重大医疗需求的两类血友病A或B患者群体

美股速递
Feb 06

美国食品药品监督管理局(FDA)已授予Hympavzi®(Marstacimab)补充生物制剂许可申请(sBLA)优先审评资格。该药物旨在治疗存在重大医疗需求的两类血友病A或B患者群体。

优先审评资格的授予,意味着FDA认为该疗法有潜力在安全性或有效性方面为患者提供显著改善。此举有望加速Hympavzi®的审批进程,为亟需新治疗选择的血友病患者带来希望。

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