FDA Approves Orladeyo Granules for Hereditary Angioedema Patients Aged 12 and Older

The U.S. Food and Drug Administration has approved a 150mg granule formulation of the hereditary angioedema prophylactic Orladeyo for patients aged 12 and older, offering an alternative for individuals who struggle to swallow traditional capsules, according to kormedi.com reporting.

FDA Clears Orladeyo Granules for Patients Aged 12 and Older

• New Approval: The FDA cleared the 150mg oral granule formulation of Orladeyo (berotralstat), expanding its use from younger children to adolescents and adults aged 12 and older.
• Administration: The small granules can be taken directly or mixed into non-acidic soft foods like pudding or mashed potatoes, avoiding acidic items like yogurt that break down the coating.
• Clinical Efficacy: Backed by existing 3rd-phase clinical data showing a 44.2% reduction in swelling attacks compared to a placebo, though it remains a preventative daily medication rather than an acute rescue treatment.

FDA Expands Orladeyo Granules to Adolescents and Adults

The decision by federal regulators on Tuesday broadens the accessibility of BioCryst Pharmaceuticals’ preventive therapy. Hereditary angioedema causes sudden, severe swelling beneath the skin and mucosal tissues due to the overactivity of a protein-cleaving enzyme called plasma kallikrein, which drives up bradykinin levels. While the capsule version of Orladeyo secured initial FDA approval in December 2020 for patients 12 and older, and a granule version was cleared for children aged 2 to 11 in December 2025, this latest regulatory update bridges the gap for older patients who cannot comfortably swallow capsules.

Acidic Foods Dissolve the Protective Granule Coating

Patients prescribed the granule formulation can pour the small drug-containing particles directly into the mouth to swallow with water or milk, or mix them into specific soft foods. Acidic foods such as yogurt must be avoided because the acid dissolves the protective coating of the granules, releasing a bitter taste. The mixture must be consumed immediately, and patients are instructed never to chew or crush the individual granules.

Orladeyo Prevents Swelling Attacks but Cannot Treat Acute Episodes

The regulatory expansion relies on safety, tolerability, and manufacturing data rather than new efficacy trials. The underlying clinical data stems from a 24-week Phase 3 trial of 120 patients aged 12 and older, where daily 150mg doses resulted in an average of 1.31 swelling attacks per 28 days compared to 2.35 attacks in the placebo group. Regulators emphasize that Orladeyo is strictly a daily preventative treatment and cannot reverse an acute attack. Patients experiencing sudden airway or tongue swelling still require immediate emergency intervention and separate acute rescue medication. Reported side effects include abdominal pain, vomiting, diarrhea, back pain, and gastrointestinal reflux, with high doses carrying risks of cardiac electrical abnormalities and arrhythmias.

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Treatment Arm	Participant Count	Average Attacks (Per 28 Days)	Study Duration
Orladeyo 150mg Daily	120 (Total trial pool)	1.31	24 Weeks
Placebo Group	120 (Total trial pool)	2.35	24 Weeks