FDA 接受 Arrowhead 的药物申请,用于治疗导致高甘油三酯的罕见遗传病。 FDA accepts Arrowhead's drug application for rare genetic disorder causing high triglycerides.
Arrowhead Pharmaceuticals 的 plozasiran 新药申请已被 FDA 接受,该药物旨在治疗家族性乳糜微粒血症综合征 (FCS),这是一种导致高甘油三酯水平的罕见遗传病。 Arrowhead Pharmaceuticals' New Drug Application for plozasiran, aimed at treating familial chylomicronemia syndrome (FCS), a rare genetic disease causing high triglyceride levels, has been accepted by the FDA. 该药物如获批准,可提供一种新的治疗办法。 The drug, if approved, could offer a new treatment option. 美国食品和药物管理局设定了2025年11月18日的行动日期,并计划此时不召开咨询委员会会议. The FDA set an action date of November 18, 2025, and plans no advisory committee meeting at this time. 箭头还打算在2025年向其他监管者提交申请。 Arrowhead also intends to submit applications to other regulators in 2025.