RESEARCH TRIANGLE PARK, N.C., July 17, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced its participation at the 2023 US Hereditary Angioedema Association (HAEA) National Summit, which will include the presentation of three abstracts featuring data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE). The US HAEA National Summit is being held in Orlando, Fla., from July 20-23, 2023.
“We are very excited and grateful to be a part of the US HAEA community gathering again for the first time since the COVID pandemic. This community played a critical role in helping our company introduce the first oral, once-daily treatment for the prevention of HAE attacks. While this is a big step forward for patients, we are just getting started and plan to continue to work tirelessly for this community,” said Jon Stonehouse, president and chief executive officer of BioCryst.
The three abstracts that BioCryst will present at the US HAEA National Summit are:
- Once-daily oral berotralstat led to improvements in work productivity and activity impairment in patients with hereditary angioedema: Results from the APeX-2 randomized Phase III trial; Poster #19; Professional Scientific Track; Friday, July 21, 2023, 7:45 am-12:20 pm ET
- Disease and Treatment Burden of Hereditary Angioedema (HAE) in Pediatric Patients: Assessment by Caregivers; Poster #4; Professional Scientific Track; Friday, July 21, 2023, 7:45 am-12:20 pm ET
- Attack-free Status in Patients who Switched from Subcutaneous Lanadelumab to Oral Berotralstat; Poster #1; Professional Scientific Track; Friday, July 21, 2023, 7:45 am-12:20 pm ET
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