BioCryst to Present New ORLADEYO (berotralstat) Data at 2023 European Academy of Allergy and Clinical Immunology Congress

RESEARCH TRIANGLE PARK, N.C., May 31, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals Inc (Nasdaq: BCRX) today announced that the company will present two abstracts featuring data on oral, once-daily ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) congress which is being held in Hamburg, Germany from June 9 – 11, 2023. 

BioCryst will present two posters at Thematic Poster Session (TPS) 41 - Dermatology 3, Poster Zone C on Sunday, June 11, 2023, from 12:45 – 13.45 CEST: 

• Berotralstat provides sustained reduction in HAE attack rates and improvement in quality of life in adolescent patients: a subgroup analysis from APeX-S. (Poster: TP-C103)

• Rapid and sustained reductions in attack rates demonstrated with berotralstat long-term prophylaxis in patients with hereditary angioedema with normal C1 inhibitor: real-world outcomes. (Poster: TP-C106)
  

About ORLADEYO (berotralstat)
ORLADEYO (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

U.S. Indication and Important Safety Information

INDICATION
ORLADEYO (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

IMPORTANT SAFETY INFORMATION
An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.

The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).