Syndax Says FDA Gives Orphan Drug Designation to Axatilimab
Syndax Says FDA Gives Orphan Drug Designation to Axatilimab
DJ Syndax Says FDA Gives Orphan Drug Designation to Axatilimab
By Stephen Nakrosis
Biopharmaceutical company Syndax Pharmaceuticals Inc. on Thursday said the U.S. Food and Drug Administration granted orphan drug designation to its axatilimab for the treatment of patients with idiopathic pulmonary fibrosis.
The FDA grants orphan drug status to treatments for rare diseases and the designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing.
"IPF is a serious, life-limiting orphan disease, and today's orphan drug designation validates axatilimab's potential to serve as an effective therapeutic option for the currently-underserved patients living with this rare disease," said CEO Briggs W. Morrison. "Building on promising data demonstrating meaningful multiorgan clinical benefit in patients with chronic graft versus host disease, we are actively evaluating options to expand the axatilimab franchise into additional areas of high unmet need where the monocyte-macrophage lineage plays a key role in the fibrotic disease process," he added.
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
April 08, 2021 16:54 ET (20:54 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
DJ Syndax Says FDA Gives Orphan Drug Designation to Axatilimab
DJ Syndax稱FDA將孤兒藥物名稱授予Axatilimab
By Stephen Nakrosis
作者：斯蒂芬·納克西
Biopharmaceutical company Syndax Pharmaceuticals Inc. on Thursday said the U.S. Food and Drug Administration granted orphan drug designation to its axatilimab for the treatment of patients with idiopathic pulmonary fibrosis.
生物製藥公司Syndax PharmPharmticals Inc.週四表示，美國食品和藥物管理局(FDA)批准其axatilimab為孤兒藥物，用於治療特發性肺纖維化患者。
The FDA grants orphan drug status to treatments for rare diseases and the designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing.
FDA授予治療罕見疾病的孤兒藥物地位，這一指定使該藥物的贊助商有資格獲得各種開發激勵措施，包括對合格的臨牀測試的税收抵免。
"IPF is a serious, life-limiting orphan disease, and today's orphan drug designation validates axatilimab's potential to serve as an effective therapeutic option for the currently-underserved patients living with this rare disease," said CEO Briggs W. Morrison. "Building on promising data demonstrating meaningful multiorgan clinical benefit in patients with chronic graft versus host disease, we are actively evaluating options to expand the axatilimab franchise into additional areas of high unmet need where the monocyte-macrophage lineage plays a key role in the fibrotic disease process," he added.
首席執行官布里格斯·W·莫里森(Briggs W.Morrison)説：“IPF是一種嚴重的、限制生命的孤兒疾病，今天的孤兒藥物名稱證實了axatilimab作為目前服務不足的這種罕見疾病患者的有效治療選擇的潛力。”他補充説：“在有希望的數據顯示慢性移植物抗宿主病患者有意義的多器官臨牀益處的基礎上，我們正在積極評估將axatilimab專營權擴大到更多未得到滿足的高需求領域的選擇，在這些領域，單核細胞-巨噬細胞系在纖維化疾病過程中發揮關鍵作用。”
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
--寫信給斯蒂芬·納克希爾斯，電子郵件：stehen.naksim@wsj.com
(END) Dow Jones Newswires
(完)道瓊通訊社
April 08, 2021 16:54 ET (20:54 GMT)
2021年4月8日16：54美國東部時間(格林尼治標準時間20：54)
Copyright (c) 2021 Dow Jones & Company, Inc.
版權所有(C)2021年道瓊斯公司
譯文內容由第三人軟體翻譯。
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