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獲得FDA孤兒稱號，用於PRGN-2012治療複發性呼吸道乳頭狀瘤病>PGEN
By Colin Kellaher
科林·凱萊赫(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.週四説，美國食品和藥物管理局(FDA)批准其PRGN-2012免疫療法用於治療複發性呼吸道乳頭狀瘤病，這是一種罕見的疾病，由喉部病毒性疣的生長引起。
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.
這家位於馬里蘭州日耳曼敦的生物製藥公司在1月份獲得了FDA的批准，開始對這種難以治療、有時甚至是致命的腫瘤疾病進行治療性疫苗的第一階段研究。
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的孤兒藥物計劃給予治療疾病和障礙的藥物和生物製品特殊地位，這些疾病和障礙在美國只有不到20萬人受到影響，並規定了針對競爭的延長市場排他期。
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説，目前還沒有治癒複發性呼吸道乳頭狀瘤病的方法，目前的護理標準是反覆內鏡下切除或切除乳頭狀瘤狀病變。
Write to Colin Kellaher at colin.kellaher@wsj.com
寫信給Colin Kellaher，電子郵件：colin.kellaher@wsj.com
(END) Dow Jones Newswires
(完)道瓊通訊社
March 18, 2021 08:54 ET (12:54 GMT)
2021年3月18日東部時間08：54(格林尼治標準時間12：54)
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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