# FDA Approves Orladeyo Pellets for Patients 12 and Older

By Riza Dagoc

Canonical URL: https://www.tokenpost.com/news/regulation/37407
Published: 2026-10-22T03:38:16.000Z
Updated: 2026-10-22T03:38:16.000Z
Section: Regulation

> The once-daily 150-milligram dose can be swallowed with water or milk or sprinkled on soft, non-acidic food.

The U.S. Food and Drug Administration approved a once-daily, 150-milligram Orladeyo pellet formulation on Oct. 21 for adults and adolescents 12 and older to prevent hereditary angioedema (HAE) attacks. The approval adds a pellet option for an age group previously covered by capsules.

Patients can take the pellets with water or milk, or sprinkle them over soft, non-acidic food. Orladeyo’s active ingredient is berotralstat, a plasma kallikrein inhibitor used to prevent HAE attacks. It is not intended to treat an acute attack.

The FDA approved Orladeyo capsules for patients 12 and older in 2020 and pellets for children ages 2 to under 12 in 2025. BioCryst President and CEO Charlie Gayer said the pellet formulation could “make administration easier for patients who have difficulty swallowing or prefer not to take a capsule.”