BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial
Reuters
Yesterday
BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial
BioCryst Pharmaceuticals Inc. has announced new data from the ongoing APeX-P clinical trial evaluating ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema $(HAE)$ aged 2 to under 12 years. The results, presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in November 2025, show early and sustained reductions in monthly HAE attack rates over one year of treatment with once-daily ORLADEYO oral granules. The company also highlighted findings on the negative psychosocial impact of HAE and emergency care visits on children and their caregivers. A New Drug Application for ORLADEYO oral granules as prophylaxis in this pediatric population is currently under review by the U.S. Food and Drug Administration, with a decision expected by the end of 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for HAE patients aged 2 to under 12 years.
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