美国食品药品监督管理局（FDA）已同意对Palvella Therapeutics公司旗下产品Qtorin™雷帕霉素的新药申请（NDA）启动滚动审评程序，该药物旨在治疗微囊性淋巴管畸形。
这一决定意味着Palvella公司可以分阶段提交NDA的相关模块，而无需等待所有资料完全齐备，从而有望加速整体的审评流程。Qtorin™雷帕霉素是一种针对罕见病微囊性淋巴管畸形开发的局部治疗药物。
获得滚动审评资格通常表明监管机构认为该药物针对的疾病领域存在未满足的医疗需求，并且初步提交的临床数据展现了积极的潜力。此举为Palvella公司推进该候选药物的上市进程提供了重要助力。
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