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称FDA将孤儿药物名称授予Axatilimab
By Stephen Nakrosis
作者：斯蒂芬·纳克西
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.
生物制药公司Syndax PharmPharmticals Inc.周四表示，美国食品和药物管理局(FDA)批准其axatilimab为孤儿药物，用于治疗特发性肺纤维化患者。
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授予治疗罕见疾病的孤儿药物地位，这一指定使该药物的赞助商有资格获得各种开发激励措施，包括对合格的临床测试的税收抵免。
"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.
首席执行官布里格斯·W·莫里森(Briggs W.Morrison)说：“IPF是一种严重的、限制生命的孤儿疾病，今天的孤儿药物名称证实了axatilimab作为目前服务不足的这种罕见疾病患者的有效治疗选择的潜力。”他补充说：“在有希望的数据显示慢性移植物抗宿主病患者有意义的多器官临床益处的基础上，我们正在积极评估将axatilimab专营权扩大到更多未得到满足的高需求领域的选择，在这些领域，单核细胞-巨噬细胞系在纤维化疾病过程中发挥关键作用。”
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
--写信给斯蒂芬·纳克希尔斯，电子邮件：stehen.naksim@wsj.com
(END) Dow Jones Newswires
(完)道琼通讯社
April 08, 2021 16:54 ET (20:54 GMT)
2021年4月8日16：54美国东部时间(格林尼治标准时间20：54)
Copyright (c) 2021 Dow Jones & Company, Inc.
版权所有(C)2021年道琼斯公司
译文内容由第三方软件翻译。
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