BioCryst Pharmaceuticals Gets Japan Approval for Orladeyo in Young Children

07:41 AM EDT, 08/25/2026 (MT Newswires) -- BioCryst Pharmaceuticals (BCRX) said Tuesday Japan approved once-daily Orladeyo to prevent hereditary angioedema attacks in children aged 2 to under 12. The company said the approval covers a granule formulation that can be swallowed with water or milk or mixed with soft food, providing an oral alternative to injections traditionally used to manage hereditary angioedema in children. The approval was based on interim results from the APeX-P clinical trial, which showed early and sustained reductions in monthly hereditary angioedema attacks, with no new safety concerns, the company said. BioCryst said it plans to launch the treatment in Japan after completing the national reimbursement process.