BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) has announced that ORLADEYO™ (berotralstat) has received FDA approval and the company will start shipments to US patients with a prescription.
ORLADEYO approved for US patients
The FDA approved once-daily, oral ORLADEYO on December 3 for prophylaxis in preventing hereditary angioedema (HAE) attacks in pediatric patients above 12 years and adults. This is the first and only oral therapy for HAE patients and each ORLADEYO capsule per day helps in preventing HAE attacks in patients by reducing plasma kallikrein activity. However, the effectiveness and safety of ORLADEYI in treating acute HAE attacks is yet to be established and therefore the therapy should not be used for severe HAE attacks
Already Optime Care Inc. which is ORLADEYO’s exclusive specialty pharmacy provider has commenced shipping to patients. Family Allergy and Asthma, Louisville’s senior partner Douglas Lotz said that access to treatment is very important for HAE patients. Lotz added that for a long most HAE patients have been longing for oral medicine and he is delighted that they have received BioCryst’s support to access ORLADEYO quickly following its approval.
The company is committed to helping HAE patients on ORLADEYO through a novel program designed to rationalize therapy access. Each healthcare provider and their patient will through the EMPOWER Patients Services receive a single point of contact for ORLADEYO access. Most importantly a committed care coordinator will also support patient access with complete financial support instruments and reimbursement support.
BioCryst serving patients through the EMPOWER program
Charlie Gayer, the company’s chief commercial officer said that BioCryst’s objective is to offer the best-in-class partnership enabling an individualized approach for patients and physicians. Gayer said that through the company’s committed care coordinators they offer assistance to healthcare providers and patients through a single point of contact to help the treatment journey. Ranging from transition to ORLADEYO, deliveries coordination, and to patient support, EMPOWER emphasizes patients support.
It is important to note that higher ORLADEYO doses of over 150 mg per day are not recommended because of the possibility of QT prolongation.