FDA授予凱瑞康寧研制的XWL-008治療發作性睡病孤兒藥資格

By PR Newswire on 24 Jun 2019

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武漢2019年6月24日 /美通社/ -- XW Laboratories Inc.（凱瑞康寧），一家臨床階段專注於開發治療神經系統疾病創新藥的生物製藥公司，今天宣布美國食品藥物監督管理局 (FDA) 授予了XWL-008用於治療發作性睡病（又稱嗜睡症）的孤兒藥資格 (Orphan Drug Designation (ODD)) 。

「我們很高興收到XWL-008用於治療發作性睡病的孤兒藥資格認證。我們將繼續致力於XWL 008的臨床開發，使其成為這種罕見疾病的潛在一線治療用藥。」凱瑞康寧的創始人，首席執行官向家寧博士說，「我們最近成功完成XWL-008臨床1期研究，是公司的一個重要里程碑。臨床1期數據顯示XWL-008具有良好的安全性，耐受性和藥代動力學特徵。我們現在正準備開展臨床3期研究並將實施505(b)(2) NDA申報途徑，盡快將這種新型候選藥物帶給全球發作性睡病患者。」