Shots:
- The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada
- NDA was supported by P-III (APeX-P) trial assessing Orladeyo as a prophylactic therapy in above pts, showing early & sustained reductions in monthly attack rates, with favorable safety as presented at AAAAI/WAO 2025
- Orladeyo (PO, QD) is a plasma kallikrein inhibitor, which was previously approved for the prophylactic prevention of HAE attacks in pts (≥12yrs.)
Ref: GlobeNewswire | Image: BioCryst| Press Release
Related News:- Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
