BioCryst Announces U.S. FDA Approval of ORLADEYO® 150 mg Oral Pellets for Adults and Adolescents with HAE
The FDA approved BioCryst's sNDA for the 150 mg oral pellet formulation of once-daily ORLADEYO (berotralstat) for prophylaxis in adults and adolescents with HAE aged 12 and older. The approval adds an administration option for patients who have difficulty swallowing or prefer not to take a capsule, making ORLADEYO the first and only targeted oral prophylactic HAE therapy with options for patients aged 2 and above.
Key figures
- Drug Name
- ORLADEYO (berotralstat) 150 mg oral pellets
- Countries approved
- more than 45
- Attack rate reduction
- 91% at 96 weeks
- Capsule initial approval
- December 2020
- Pediatric pellet approval
- December 2025 (ages 2 to <12)
- Rescue medication reduction
- 88%
AI analysis
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