Arrowhead's Plozasiran Meets All Primary and Secondary Endpoints in Phase 3 Study, To Seek FDA Approval
Arrowhead's Plozasiran Meets All Primary and Secondary Endpoints in Phase 3 Study, To Seek FDA Approval
Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) today announced results from the Phase 3 PALISADE study of investigational plozasiran in patients with familial chylomicronemia syndrome (FCS), a severe and rare genetic disease which currently has no approved treatments in the U.S. PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides (TGs), apolipoprotein C-III (APOC3), and the incidence of acute pancreatitis (AP). These data were presented today in a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2024 and simultaneously published in The New England Journal of Medicine.
納斯達克（NASDAQ:ARWR）今天宣佈了一項第三階段PALISADE研究的結果，該研究調查了 investigational plozasiran 在患有家族性乳糜微囊症（FCS）的患者中的應用情況。FCS是一種嚴重而罕見的遺傳病，在美國目前沒有批准的治療方法。PALISADE成功達到了主要終點和所有多重控制的關鍵次要終點，包括甘油三酯（TGs）、載脂蛋白C-III（APOC3）的顯著降低以及急性胰腺炎（AP）的發生率。這些數據今天在2024年歐洲心臟病學會（ESC）大會的一次開幕演講中發佈，並同時發表於《新英格蘭醫學雜誌》。
Based on these positive findings from the PALISADE study, Arrowhead intends to file a New Drug Application with the United States Food and Drug Administration (FDA) by year-end 2024 and plans to seek regulatory approval with additional global regulatory authorities thereafter.
基於PALISADE研究的這些積極發現，Arrowhead打算在2024年年底前向美國食品藥品監督管理局（FDA）提交新藥申請，並計劃隨後向其他全球監管機構尋求批准。
譯文內容由第三人軟體翻譯。
