RESEARCH TRIANGLE PARK, N.C., June 22, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced multiple upcoming data presentations at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022 from July 1-3, 2022, at the O2 universum in Prague, Czech Republic.
Details of the three abstracts that will be presented in Flash Talks sessions include:
- Attack-free Status in Patients who Switched from Subcutaneous Lanadelumab to Oral Berotralstat; Abstract #311; FT 3 – Flash Talks on hereditary angioedema; Friday, July 1, 2022; 11:15am-12:45pm CET; Room D7
- Improvement in Quality of Life and Hereditary Angioedema (HAE) Attack Rates Observed in Patients Treated with Long-term Berotralstat in the APeX-2 Study; Abstract #312; FT 3 – Flash Talks on hereditary angioedema; Friday, July 1, 2022; 11:15am-12:45pm CET; Room D7
- 96 Weeks of Treatment with Berotralstat Consistently Decreases the Use of Injectable On-Demand Medication to Treat Hereditary Angioedema (HAE) Attacks: Analysis from APeX-2; Abstract #313; FT 24 – Flash Talks on urticaria and angioedema II; Sunday, July 3, 2022; 5:15-6:45pm CET; Room D6
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
INDICATIONORLADEYO® (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 useThe 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 INFORMATIONAn 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).
Berotralstat is a substrate of P-gp and BCRP. 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