FDA — authorised 3 December 2020
- Application: NDA214094
- Marketing authorisation holder: BIOCRYST
- Local brand name: ORLADEYO
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Orladeyo in United States
FDA authorised Orladeyo on 3 December 2020
Marketing authorisations
FDA — authorised 11 December 2025
- Application: NDA219776
- Marketing authorisation holder: BIOCRYST
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Orladeyo, a new dosage form, for marketing by BIOCRYST on 11 December 2025. This approval was granted under the standard expedited pathway. The application number for this approval is NDA219776.
Orladeyo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Orladeyo approved in United States?
Yes. FDA authorised it on 3 December 2020; FDA authorised it on 11 December 2025.
Who is the marketing authorisation holder for Orladeyo in United States?
BIOCRYST holds the US marketing authorisation.