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吉利德科学公司称其HIV联合疗法新药申请获得FDA优先审查

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-- 吉利德科学公司(GILD)周三宣布,美国食品药品监督管理局(FDA)已受理其每日一次的HIV治疗药物新药申请,该药物为比克替拉韦和来那卡帕韦的复方制剂,并授予优先审评资格,预计审批日期为8月27日。 该公司表示,该申请基于ARTISTRY-1和ARTISTRY-2两项III期临床试验,结果显示该方案在48周内维持了病毒抑制,且在HIV感染成人患者中总体耐受性良好,包括那些从多片复方制剂或Biktarvy转换而来的患者。 该公司还表示,比克替拉韦75毫克和来那卡帕韦50毫克的复方制剂目前仍处于研究阶段,尚未在全球范围内获批,其安全性和有效性尚待进一步证实。

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