FDA Approves BioCryst Pharma’s sNDA For Use Of Oral Pellet Formulation Of Once-Daily ORLADEYO For Prophylactic Therapy In Adults And Adolescents Aged 12 Years And Older

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has received FDA approval for its supplemental New Drug Application (sNDA) for the oral pellet formulation of ORLADEYO (berotralstat), intended for prophylactic therapy in adults and adolescents aged 12 and older. This new 150 mg pellet option caters to patients who have difficulty swallowing capsules and allows for once-daily administration. The approval expands BioCryst's portfolio of targeted oral prophylactic therapies for hereditary angioedema (HAE) patients.