BioCryst Pharmaceuticals, Inc. announced that the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina has granted approval for oral, once-daily ORLADEYO®? (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older. The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.