BioCryst gets FDA approval for ORLADEYO oral pellets for HAE patients aged 2 to <12 years

BIOCRYST PHARMACEUTICALS INC

FDA approved ORLADEYO oral pellet formulation for prophylactic therapy in HAE children aged 2 to <12 years.
First and only oral prophylactic treatment for this age group; previously only injectable options were available.
Approval supported by APeX-P trial interim data showing early and sustained attack rate reductions with no new safety signals.
BioCryst plans EU, Japan, and other regulatory filings; ORLADEYO capsule already approved for ages 12+ since Dec 2020.
More than 3,500 patients in the US have been prescribed ORLADEYO to date.

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