Precigen Gets FDA Orphan Designation for PRGN-2012 in Recurrent Respiratory Papillomatosis >PGEN
Precigen Gets FDA Orphan Designation for PRGN-2012 in Recurrent Respiratory Papillomatosis >PGEN
DJ Precigen Gets FDA Orphan Designation for PRGN-2012 in Recurrent Respiratory Papillomatosis >PGEN
By Colin Kellaher
Precigen Inc. on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its PRGN-2012 immunotherapy for recurrent respiratory papillomatosis, a rare condition caused by the growth of viral warts in the larynx.
The Germantown, Md., biopharmaceutical company in January received FDA approval to begin a Phase 1 study of the therapeutic vaccine in the hard-to-treat and sometimes fatal neoplastic disease.
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.
Precigen said there is currently no cure for recurrent respiratory papillomatosis, and the current standard-of-care is repeated endoscopic debulking with ablation or excision of papillomatous lesions.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 18, 2021 08:54 ET (12:54 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
DJ Precigen Gets FDA Orphan Designation for PRGN-2012 in Recurrent Respiratory Papillomatosis >PGEN
DJ Precigen获得FDA孤儿称号，用于PRGN-2012治疗复发性呼吸道乳头状瘤病>PGEN
By Colin Kellaher
科林·凯莱赫(Colin Kellaher)著
Precigen Inc. on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its PRGN-2012 immunotherapy for recurrent respiratory papillomatosis, a rare condition caused by the growth of viral warts in the larynx.
Precigen Inc.周四说，美国食品和药物管理局(FDA)批准其PRGN-2012免疫疗法用于治疗复发性呼吸道乳头状瘤病，这是一种罕见的疾病，由喉部病毒性疣的生长引起。
The Germantown, Md., biopharmaceutical company in January received FDA approval to begin a Phase 1 study of the therapeutic vaccine in the hard-to-treat and sometimes fatal neoplastic disease.
这家位于马里兰州日耳曼敦的生物制药公司在1月份获得了FDA的批准，开始对这种难以治疗、有时甚至是致命的肿瘤疾病进行治疗性疫苗的第一阶段研究。
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.
FDA的孤儿药物计划给予治疗疾病和障碍的药物和生物制品特殊地位，这些疾病和障碍在美国只有不到20万人受到影响，并规定了针对竞争的延长市场排他期。
Precigen said there is currently no cure for recurrent respiratory papillomatosis, and the current standard-of-care is repeated endoscopic debulking with ablation or excision of papillomatous lesions.
Precigen说，目前还没有治愈复发性呼吸道乳头状瘤病的方法，目前的护理标准是反复内镜下切除或切除乳头状瘤状病变。
Write to Colin Kellaher at colin.kellaher@wsj.com
写信给Colin Kellaher，电子邮件：colin.kellaher@wsj.com
(END) Dow Jones Newswires
(完)道琼通讯社
March 18, 2021 08:54 ET (12:54 GMT)
2021年3月18日东部时间08：54(格林尼治标准时间12：54)
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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