BioCryst’s Hereditary Angiodema Tablet Wins FDA Approval

December 8, 2020

BioCryst Pharmaceuticals has received FDA approval for Orladeyo (berotralstat) for the prevention of hereditary angioedema (HAE) attacks in adults and children 12 years and older.

The approval was supported by results from a phase 3 trial in which the drug was shown to significantly reduce attacks at 24 weeks, with the reduction continuing for 48 weeks. The most common side effect was gastrointestinal distress.

Orladeyo was approved in a 150-mg, once-daily oral tablet. It is the first orally administered, nonsteroidal treatment for the rare disorder.

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