BioCryst Pharmaceuticals, Inc. announces 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 3 December 2020 for prophylaxis to prevent attacks of 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,” says 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.”
Orladeyo is the first and only oral therapy designed specifically to prevent attacks of 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.