197 0 Kommentare BioCryst to Present New Data at 2024 Meeting of the European Academy of Allergy and Clinical Immunology

RESEARCH TRIANGLE PARK, N.C., May 14, 2024 (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 Valencia, Spain from May 31 to June 3, 2024.

BioCryst will present two abstracts at the meeting:

Adverse Health Outcomes and Patient and Physician Perspectives of Attenuated Androgen Use in Hereditary Angioedema. Session #TPS27, Poster #D1.458 – Prevention, Poster Zone, Friday, May 31, 2024, from 12:00 – 13.00 (CEST)
Effectiveness and Safety of Berotralstat in Patients with Hereditary Angioedema with Normal C1 Inhibitor: A European Case Series. Session #OAS 19 Oral Abstract Session: Room - Bilbao, Sunday, June 2, 2024, from 09:06 to 09:18 (CEST)

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.

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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.

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