By Colin Kellaher
BioCryst Pharmaceuticals has won U.S. Food and Drug Administration priority review for an application seeking expanded approval of its Orladeyo hereditary-angioedema drug for children ages 2 through 11.
BioCryst on Wednesday said an FDA green light would make Orladeyo the first targeted oral prophylactic therapy for children under the age of 12 with hereditary angioedema, a genetic disorder characterized by recurrent episodes of severe swelling.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. BioCryst said the agency set a target action date of Sept. 12 for the application.
The FDA approved Orladeyo in December 2020 to prevent hereditary-angioedema attacks in patients 12 and older.
BioCryst, a Durham, NC., biotechnology company, earlier this month raised its 2025 global Orladeyo revenue forecast to $580 million to $600 million from a prior range of $535 million to $550 million.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 14, 2025 07:33 ET (11:33 GMT)
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