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FDA Approves ORLADEYO Pellets for Patients 12 and Older

lite News Desk 1 min read

BioCryst’s supplemental application for 150 mg ORLADEYO (berotralstat) oral pellets has received FDA approval, according to the company’s October 21, 2026 announcement. The approval covers a once-daily dose for hereditary angioedema attack prevention in people aged 12 or older.

According to BioCryst, ORLADEYO inhibits plasma kallikrein and is used for prevention, not treatment of an acute hereditary angioedema attack.

The company said the pellet formulation provides an option for adults and adolescents who find capsules difficult to swallow or prefer a different formulation. It is also intended for patients who want to remain on pellets after their 12th birthday. For administration, BioCryst said the pellets may be taken with milk or water, or added to a spoonful of food that is soft and non-acidic.

BioCryst said the information supporting the FDA decision included a comparison of safety and tolerability between the pellets and ORLADEYO capsules. The agency also relied on information covering chemistry, manufacturing and controls, according to the company.

The announcement places the new approval alongside two earlier FDA decisions. BioCryst said capsules received approval in December 2020 for patients 12 and older, while approval of the pellet formulation for children from age 2 to under 12 came in December 2025.

* This article is based on publicly available information at the time of writing.

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