BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present four abstracts featuring data on oral, once-daily ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, which is being held in San Antonio, Texas, from February 24-27, 2023.

We continue to build a consistent library of evidence that showcases the value of ORLADEYO through a combination of new analyses from our long-term clinical program and real-world evidence,' said Dr. Ryan Arnold, chief medical officer of BioCryst. 'From new real-world evidence that further demonstrates a meaningful reduction in attack rates experienced by patients who are on ORLADEYO, to additional analyses detailing sustained improvements in patient-reported QoL, the findings that we will present at AAAAI continue to show that our oral, once-daily prophylactic therapy is making a difference for many patients living with HAE.'

The four abstracts that BioCryst will present are: Disease and Treatment Burden of Hereditary Angioedema (HAE) in Pediatric Patients: Assessment by Caregivers; Poster 417; Sunday, February 26, 9:45-10:45 am CT

Long-term HAE Prophylaxis with Berotralstat Is Well Tolerated and Effective: Analysis for the APeX-S Study; Poster 398; Sunday, February 26, 9:45-10:45 am CT

Berotralstat Improved Quality of Life through 96 Weeks Across Multiple Subgroups of Patients with Hereditary Angioedema; Poster 426; Sunday, February 26, 9:45-10:45 am CT

Real-World Outcomes in Patients with Hereditary Angioedema (HAE) Treated with Berotralstat; Poster 415; Sunday, February 26, 9:45-10:45 am CT

The abstracts are now available to view in an online supplement to The Journal of Allergy and Clinical Immunology (JACI) at jacionline.org.

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

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