BioCryst Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the company's new drug application for ORLADEYO® (berotralstat) oral granules. This extension pertains to the use of the medication in pediatric patients aged 2 to 11 years with hereditary angioedema $(HAE)$. The FDA's decision to extend the deadline by three months, now set for December 12, 2025, follows the submission of additional final reports and formulation data by BioCryst, which were deemed a major amendment to the application. This extension allows the FDA ample time to conduct a thorough review of the new information.
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