FDA批准BioCryst的ORLADEYO 150mg口服颗粒剂用于12岁及以上HAE预防，属剂型扩展

BioCryst Pharmaceuticals ( BCRX ) on Wednesday announced the FDA approval of a new oral pellet formulation of its bestselling product, Orladeyo, marking a label expansion for the once-daily therapy, approved in the U.S. for a rare genetic condition called hereditary angioedema. Approving the company’s supplemental New Drug Application, the FDA has permitted the use of Orladeyo 150 mg oral pellets as a prophylactic therapy for patients aged 12 years and older with HAE. In December 2020, the agency first approved a capsule formulation of Orladeyo for those aged 12 years and older with HAE and, in December, expanded its label as an oral pellet formulation for patients aged 2–12 years. The new formulation is designed to provide an alternative administration method for patients with swallowing difficulties and those who prefer to continue a pellet formulation after reaching 12 years, the company said.