BioCryst Announces U.S. FDA Approval of ORLADEYO® 150 mg Oral Pellets for Adults and Adolescents with HAE
Globe Newswire•21/10/2026•07:00 ET
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Key Highlights
- ➤FDA approves ORLADEYO 150 mg oral pellets for adults and adolescents aged 12 years and older
- ➤Pellets expand once-daily ORLADEYO administration beyond capsules for patients preferring or needing alternative dosing
- ➤ORLADEYO is now approved for HAE prophylaxis in patients aged 2 years and older
- ➤ORLADEYO capsules reduced HAE attack rates 91% at 96 weeks
- ➤ORLADEYO capsules reduced rescue medication use 88% in clinical studies
Expert Statements
Charlie Gayer, President and Chief Executive Officer of BioCryst
“We are focused on advancing HAE attack prevention through a portfolio of therapies designed to support the diverse needs and preferences of patients.”
Charlie Gayer, President and Chief Executive Officer of BioCryst
“The approval of ORLADEYO pellets for adults and adolescents strengthens our ability to provide personalized treatment choice by offering the proven efficacy of ORLADEYO in a new formulation to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule.”
Charlie Gayer, President and Chief Executive Officer of BioCryst
“This milestone reflects our commitment to optimizing the management of HAE with proven therapies that help address the evolving needs of patients across the treatment landscape.”
—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 patients aged 2 and above—
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