—Direct to patient shipments of the first oral, once-daily prophylactic treatment underway through Optime Care—
—EMPOWER Patient Services providing streamlined, single point of contact access to therapy and reimbursement support—
RESEARCH TRIANGLE PARK, N.C., Dec. 16, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that oral, once-daily ORLADEYO™ (berotralstat) is now available for shipment to patients with a prescription in the United States.
ORLADEYO was approved by the U.S. Food and Drug Administration (FDA) on December 3, 2020 for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. Optime Care, Inc., the exclusive specialty pharmacy provider for ORLADEYO, has begun shipping to patients today.
“Access to medicine is critical to HAE patients. Many patients have been waiting for an oral option and I am very pleased that they have support from BioCryst to access ORLADEYO so quickly following FDA approval,” said Douglas R. Lotz, M.D., senior partner, Family Allergy & Asthma, Louisville, KY.
BioCryst is committed to supporting HAE patients taking ORLADEYO through a new program designed to streamline access to therapy. Through EMPOWER Patient Services, each HAE patient and their healthcare provider will have a single point of contact for access to ORLADEYO. A dedicated care coordinator will support access for each patient with comprehensive financial support tools and reimbursement support.
“Our goal is to provide a best-in-class partnership that enables an individualized approach for physicians and their patients,” said Charlie Gayer, chief commercial officer of BioCryst. “Through our dedicated care coordinators, we offer a single point of contact to assist patients and healthcare providers throughout the treatment journey. From the transition to ORLADEYO, coordination of deliveries, to ongoing patient support, EMPOWER puts the HAE patient at the center.”
Additional information is available at www.ORLADEYO.com and 1-866-5-EMPOWER (1-866-536-7693).
About ORLADEYO™ (berotralstat) ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults 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