ORLADEYO™ (berotralstat) is an oral, is a once-daily capsule that prevents hereditary angioedema (HAE) attacks by inhibiting plasma kallikrein. In December 2020, the U.S. FDA approved ORLADEYO for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years of age and older. It is not known if ORLADEYO is safe and effective to treat an acute HAE attack, therefore ORLADEYO should not be used to treat an acute HAE attack. For additional information, please visit www.ORLADEYO.com, and for full prescribing information, click here.
The company also has regulatory applications under review with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA).