RESEARCH TRIANGLE PARK, N.C., Feb. 01, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present three abstracts featuring new data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2022 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, which is being held live in Phoenix, Arizona, and virtually, from February 25-28, 2022.
“The long-term data from our APeX-2 pivotal trial continues to demonstrate that ORLADEYO delivers sustained reductions in attack rates and improvement in quality of life among patients living with HAE,” said Dr. William Sheridan, chief medical officer of BioCryst. “These insights highlight the value ORLADEYO provides to the HAE community as an oral, once-daily prophylactic treatment option to help manage HAE attacks. We look forward to presenting our findings at the AAAAI annual meeting later this month.”
The three abstracts that BioCryst will present include:
- Sustained Reductions in Hereditary Angioedema (HAE) Attack Rates Observed over 96 Weeks of Oral Berotralstat Treatment Regardless of Initial Response; Poster #490
- Oral Berotralstat Treatment for 96 Weeks Consistently Reduces Hereditary Angioedema (HAE) Attack Rates Regardless of Baseline Attack Rate; Poster #491
- Sustained Improvement Observed in Patient-Reported Quality of Life (QoL) with 96 Weeks of Oral Berotralstat Treatment; Poster #492
The abstracts are now available to view in an online supplement to The Journal of Allergy and Clinical Immunology (JACI).
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).
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