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FDA Approves BioCryst Pharma’s sNDA For Use Of Oral Pellet Formulation Of Once-Daily ORLADEYO For Prophylactic Therapy In Adults And Adolescents Aged 12 Years And Older

BenzingaBenzinga Newsdesk

—Expands BioCryst portfolio of targeted oral prophylactic therapy options to meet patients’ individual needs and preferences— —ORLADEYO is the first and only targeted oral prophylactic therapy with options for HAE

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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.