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

—Expands BioCryst portfolio of targeted oral prophylactic therapy options to meet patients’ individual needs and preferences— 

—ORLADEYO is the first and only targeted oral prophylactic therapy with options for HAE patients aged 2 and above—

RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for use of the oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg ORLADEYO pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. 

With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered ORLADEYO for prophylaxis to prevent attacks of HAE in either capsule or pellet formulation. The ORLADEYO pellet formulation is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.