Hereditary Angioedema (HAE)
BioCryst is seeking to revolutionize treatment for Hereditary Angioedema (HAE) by developing orally-administered drugs to prevent and control HAE attacks
Our lead compound, ORLADEYO™ (berotralstat), is designed to be an oral, once-daily capsule that prevents attacks by inhibiting plasma kallikrein. In December 2019, BioCryst submitted a new drug application to the U.S. Food and Drug Administration seeking approval of oral, once-daily ORLADEYO for the prevention of HAE attacks.
The company also has regulatory applications under review with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA). Information about the ORLADEYO Early Access Program in the United States can be found here.
ORLADEYO is investigational and has not been deemed safe and effective by the FDA