BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years

BioCryst Pharmaceuticals has received FDA approval for a new oral pellet formulation of ORLADEYO® (berotralstat) for preventing attacks of hereditary angioedema (HAE) in pediatric patients aged 2 to under 12 years. This approval makes ORLADEYO the first and only oral prophylactic therapy available for this young patient population, addressing a significant unmet need as previous targeted treatments required intravenous or subcutaneous administration.