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)
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