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BioCryst Announces U.S. FDA Approval of ORLADEYO® 150 mg Oral Pellets

Fiscal.ai

BioCryst Pharmaceuticals received U.S. FDA approval for its new 150 mg oral pellet formulation of ORLADEYO (berotralstat) for the prevention of hereditary angioedema (HAE) attacks.

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  1. Globenewswire IncBiocryst Pharmaceuticals, Inc.

    BioCryst Announces U.S. FDA Approval of ORLADEYO® 150 mg Oral Pellets for Adults and Adolescents with HAE

    BioCryst Pharmaceuticals announced FDA approval of ORLADEYO 150 mg oral pellets for adults and adolescents aged 12 and older with hereditary angioedema (HAE). The new pellet formulation provides an alternative to capsules for patients with difficulty swallowing or those who prefer pellet administration. ORLADEYO remains the first and only targeted oral prophylactic therapy for HAE patients aged 2 and above, with clinical data showing 91% attack-rate reduction at 96 weeks.