FDA Approves ORLADEYO Pellets for Hereditary Angioedema
The 150 mg oral pellets offer a new, once-daily preventative treatment option for adults and adolescents aged 12 and older.
Updated on Oct. 21, 2026 in Allergies
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The FDA has expanded the approval for ORLADEYO oral pellets to include adults and adolescents aged 12 and older with hereditary angioedema. This provides a once-daily preventative treatment option for patients who prefer not to swallow capsules.
Why it matters
Hereditary angioedema is a chronic condition causing unpredictable swelling, and this new formulation offers a more accessible administration route for patients who struggle with swallowing pills. The approval supports ongoing disease management by diversifying how this preventative therapy can be taken.
The FDA approval was based on chemistry, manufacturing, and controls data demonstrating safety and tolerability comparable to existing capsule versions. Clinical evidence from previous studies shows a 91% mean attack-rate reduction and 88% reduction in rescue medication use over 96 weeks.
The players
FDA
The federal agency responsible for evaluating the safety and efficacy of medical products in the United States.
BioCryst
A pharmaceutical company headquartered in Research Triangle Park, N.C., that develops oral small-molecule medicines.
The details
ORLADEYO acts as a plasma kallikrein inhibitor, helping to control the sudden swelling episodes characteristic of hereditary angioedema. The new 150 mg oral pellets are designed for daily prophylactic use and can be consumed by pouring the contents directly into the mouth or sprinkling them over non-acidic soft foods. This formulation provides a practical alternative to the traditional capsule format for patients 12 and older.
Timeline
December 2020: FDA approved ORLADEYO capsules for patients 12 and older.
December 2025: FDA approved ORLADEYO pellets for pediatric patients aged 2 to 11.
October 21, 2026: FDA approved 150 mg ORLADEYO pellets for adults and adolescents.
Health Landscape
This approval follows a trend of increasing patient-centered administration options within the hereditary angioedema treatment space. By adding a pellet formulation to the existing capsule market, manufacturers are addressing specific adherence barriers for patients with swallowing difficulties.
Patients aged 12 and older who currently struggle with capsule intake or prefer an alternative may find this pellet formulation easier to incorporate into their daily routine. It is worth discussing with your doctor whether this new administration method is appropriate for your specific treatment plan.
The takeaway
The expansion of treatment options helps normalize daily care for those living with hereditary angioedema. Always coordinate with your healthcare provider before making any changes to your prescribed prophylactic therapy schedule.
Further reading
For more information on managing hereditary angioedema, visit our Allergies section.
More information
Review the full ORLADEYO patient and prescribing information to learn about this therapy.
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