BioCryst Pharmaceuticals, Inc.

BioCryst Announces Approval of ORLADEYO® for Pediatric HAE Patients in Japan

Japan's Ministry of Health, Labor and Welfare approved ORLADEYO (berotralstat) granule formulation for prophylactic therapy in pediatric HAE patients aged 2 to <12 years. This marks the second regulatory approval for ORLADEYO in Japan and expands the company's market reach for its once-daily oral treatment. The approval is based on positive interim results from the APeX-P clinical trial showing the drug was well-tolerated with sustained reductions in monthly attack rates.