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FDA approves BioCryst's oral pellet formulation of rare disease drug for young children
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FDA approves BioCryst's oral pellet formulation of rare disease drug for young children
Mar 10, 2026 10:20 PM

Dec 12 (Reuters) - The U.S. Food and Drug Administration

has approved an oral pellet formulation of BioCryst

Pharmaceuticals' ( BCRX ) drug to prevent hereditary angioedema

attacks in children aged 2 to under 12, the company said on

Friday.

The drug, Orladeyo, was already approved as a once-daily

capsule for patients aged 12 and older in December 2020.

With the FDA's latest decision, the drug becomes the first

oral treatment available for younger children with hereditary

angioedema, a rare genetic disorder that can cause sudden and

sometimes life-threatening swelling in the face, throat and

other parts of the body.

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