BioCryst Wins FDA Approval for ORLADEYO Pellets for HAE Patients 12+

The U.S. Food and Drug Administration (FDA) approved BioCryst Pharmaceuticals’ supplemental New Drug Application for the oral pellet formulation of once-daily ORLADEYO® (berotralstat). The approval covers prophylactic treatment of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

The 150 mg pellets offer an alternative for patients who have difficulty swallowing capsules or prefer another method of administration. Patients can take the pellets directly or sprinkle them on soft, non-acidic food.

BioCryst said the expanded labeling offers more flexible treatment options for HAE patients. The company also said ORLADEYO is the first and only targeted oral prophylactic therapy with treatment options for HAE patients aged 2 and older.