FDA Approves New ORLADEYO Oral Pellets for HAE
The FDA has approved the 150 mg oral pellet formulation of ORLADEYO for patients aged 12 and older with hereditary angioedema.
Updated on Oct. 21, 2026 in Allergies
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The FDA has granted approval for a 150 mg oral pellet formulation of ORLADEYO, a once-daily prophylactic treatment for hereditary angioedema. This new option is indicated for adults and adolescents aged 12 years and older.
Why it matters
The pellet formulation offers a necessary alternative for patients who struggle to swallow capsules or prefer a different administration method. It maintains the therapeutic benefits of the plasma kallikrein inhibitor while increasing accessibility for a broader patient population.
The approval is supported by clinical efficacy data showing a 91% mean attack-rate reduction and an 88% reduction in rescue medication use over a 96-week study period.
The players
FDA
The Food and Drug Administration is the federal agency responsible for regulating food, drugs, and medical devices in the United States.
ORLADEYO
ORLADEYO is a prophylactic treatment and plasma kallikrein inhibitor used to manage hereditary angioedema.
BioCryst
BioCryst is a biotechnology company headquartered in Research Triangle Park, N.C., that develops oral treatments for rare diseases.
The details
Patients can take the 150 mg ORLADEYO oral pellet by pouring it directly into the mouth or sprinkling it over non-acidic, soft foods. The approval process focused on chemistry, manufacturing, and controls data to ensure the new pellet delivery method provides the same safety and tolerability profile as existing capsule versions.
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 ORLADEYO 150 mg pellets for adults and adolescents.
The Big Picture
This approval follows the standard regulatory path established by the FDA's supplemental New Drug Application approval process for modifications to existing therapies. It reflects a broader trend of manufacturers seeking to improve treatment adherence by offering diverse administration methods for chronic conditions.
Patients with hereditary angioedema who have difficulty swallowing pills now have a flexible administration option that can be mixed with food or liquids. This update allows for a more personalized daily treatment routine while maintaining the proven prophylactic efficacy of the medication.
The takeaway
This approval highlights the importance of patient-centered drug delivery for chronic health management. Those considering this new formulation should consult with their healthcare provider to determine if the pellet option is appropriate for their specific treatment plan.
Further reading
For additional context on treatments for hereditary angioedema, visit our Allergies section.
More information
For full details, read the ORLADEYO patient and prescribing information.
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