ORLADEYO™ (berotralstat) is an oral, once-daily capsule that prevents hereditary angioedema (HAE) attacks by inhibiting plasma kallikrein. ORLADEYO is approved in the U.S. and Japan 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 U.S. prescribing information, click here.
The company also has a regulatory application under review with the European Medicines Agency (EMA).