BioCryst to Present New Data at 2025 Meeting of the European Academy of Allergy and Clinical Immunology

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RESEARCH TRIANGLE PARK, N.C. , June 02, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that new data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Glasgow, United Kingdom , from June 13 to 16, 2025 . BioCryst will present four abstracts at the meeting: Impact of Berotralstat on Quality of Life among Patients with Hereditary Angioedema: Pooled Analysis of the APeX-2 and APeX-J Trials. Session #TPS40, poster #D2.329, poster zone, Saturday, June 14, 2025 , from 12:00-13:00 (BST). Patients with HAE Report Positive Perceptions Following Berotralstat Treatment: Results from a Focus Group . Session #TPS40, poster #D2.332, poster zone, Saturday, June 14, 2025 , from 12:00-13:00 (BST). Assessment of the Effectiveness and Tolerability of Berotralstat for Long-term Prophylaxis in Hereditary Angioedema: Findings from the Berolife Study . Session #FT16, Dochart 1 room, Sunday, June 15 , from 14:14 to 14:21 (BST). Berotralstat Use Reduced Number of HAE Attacks Requiring Treatment or Professional Care in Pediatric Patients: Interim Results from APeX-P . Session #FT16, Dochart 1 room, Sunday, June 15, 2025 , from 14:35 to 14:42 (BST). 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). Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO. ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO. The safety and effectiveness of ORLADEYO in pediatric patients

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