BioCryst announces FDA approved NDA for of ORLADEYO

BioCryst (BCRX) Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has approved its New Drug Application, NDA, for the use of an oral pellet formulation of once-daily ORLADEYO for prophylactic therapy in pediatric patients with hereditary angioedema, HAE, aged 2 to less than12 years. “Today’s pediatric approval of ORLADEYO offers a welcome oral preventive choice for children living with HAE and provides families and clinicians with an important option for shared decision-making that matches treatment with patient needs,” said Anthony Castaldo, CEO and chairman of the U.S. Hereditary Angioedema Association.