Health Canada approves oral, once-daily ORLADEYO® (berotralstat) from BioCryst Pharmaceuticals, Inc. for the routine prevention of recurrent HAE attacks in patients 12 years and older.
“Today is a momentous day for the Canadian HAE community,” says Jacquie Badiou, President of HAE Canada. “HAE carries with it a severe burden on patients and their families, much of which stems from the unpredictable attacks they experience even when actively managing their disease. We have seen important treatment advancements in recent years, and I believe the first oral preventive therapy for HAE will be a welcome option for many Canadians who are living with this rare condition.”
“I believe this oral, once-daily prophylactic therapy will be a meaningful treatment option for patients who need a prophylactic therapy to help manage their HAE by reducing the frequency of attacks,” says Stephen Betschel, HBSc, MD, FRCPC, FAAAAI, Chair of the Canadian Hereditary Angioedema Network.
“We appreciate Health Canada’s thorough and timely review of ORLADEYO, and with this authorization we are one step closer to bringing this important treatment option to Canadians living with HAE,” says Jared Rhines, General Manager of BioCryst Canada. “We look forward to working with stakeholders across the country to ensure these Canadians can receive timely and appropriate access to ORLADEYO. Further, this authorization follows approvals in the US, Europe and other markets, highlighting our ongoing commitment to individuals living with rare diseases regardless of geography.”
ORLADEYO was safe and well tolerated in clinical trials. The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were gastrointestinal reactions. These reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.