FDA approves a pellet form of Orladeyo for hereditary angioedema prevention in adults and adolescents

BioCryst Pharmaceuticals announced on 21 October 2026 that the US Food and Drug Administration has approved a supplemental application for a 150 mg oral-pellet formulation of Orladeyo (berotralstat) for preventing attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older.

What changes

• HAE is a rare inherited condition that causes recurring episodes of swelling. Orladeyo is taken once a day by mouth to prevent attacks; until now, patients 12 and older took it as a capsule.
• The new pellets are small granules that can be poured into the mouth and swallowed with water or milk, or sprinkled on a spoonful of soft, non-acidic food. BioCryst says the option is meant for people who have trouble swallowing, prefer not to take capsules, or started on pellets as children and want to stay on them after age 12.
• According to the company, Orladeyo is the only targeted oral preventive therapy for HAE with options for patients aged 2 and above.

The evidence behind the drug

The approval concerns a new formulation of an already approved medicine, not new efficacy data. BioCryst cites two clinical studies of the capsules, in which it reports a mean 91% reduction in attack rate at 96 weeks and an 88% reduction in use of rescue medication. The most common side effects versus placebo were gastrointestinal reactions and back pain; the company says the stomach-related effects usually appeared early and eased over time.

Caveat

The figures come from the manufacturer’s press release. Patients with HAE should talk to their doctor about which preventive treatment and formulation suits them.