Morningstar

BioCryst Gets FDA OK for Pediatric Use of Orladeyo

Provided by Dow Jones

By Colin Kellaher 




  BioCryst Pharmaceuticals has won U.S. Food and Drug Administration approval for the expanded use of its Orladeyo hereditary-angioedema drug for children ages 2 through 11. 



  BioCryst on Friday said the green light makes 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 in May granted priority review to BioCryst's application seeking the expanded approval, with a target action date in September. The agency in June extended the target date to Dec. 12 after the Durham, N.C., biotechnology company submitted additional final reports and formulation data. 



  The FDA approved Orladeyo in December 2020 to prevent hereditary-angioedema attacks in patients 12 and older. 



  Trading in shares of BioCryst, which closed Thursday at $7.58, was halted premarket on Friday. 





  Write to Colin Kellaher at colin.kellaher@wsj.com 





  (END) Dow Jones Newswires



  December 12, 2025 07:23 ET (12:23 GMT)


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