Pharvaris’s 20 mg Oral HAE Therapy NDA Accepted with PDUFA April 23, 2027
PHVS•FDA accepted the New Drug Application for the 20 mg deucrictibant immediate-release capsule for on-demand hereditary angioedema treatment with a PDUFA action date of April 23, 2027. The Phase 3 RAPIDe-3 study met all primary and 11 secondary endpoints in over 1,300 attacks, showing median symptom relief in 1.28 hours and full resolution in 11.95 hours.
1. FDA Acceptance of Deucrictibant NDA
The FDA has accepted the New Drug Application for the 20 mg deucrictibant immediate-release capsule for on-demand treatment of hereditary angioedema and set a PDUFA target action date of April 23, 2027.
2. Phase 3 RAPIDe-3 Trial Data
In the global, placebo-controlled Phase 3 RAPIDe-3 study, over 1,300 HAE attacks were treated. The trial met its primary and all 11 secondary efficacy endpoints, with a median time to symptom relief of 1.28 hours, median End of Progression in 17.48 minutes, and complete resolution in 11.95 hours, alongside a well-tolerated safety profile.
3. Orphan Designation and Mechanism
Deucrictibant is the first oral bradykinin B2 receptor antagonist targeting bradykinin-mediated angioedema. It holds orphan drug designations from the FDA, European Commission, and Swissmedic.
4. Commercial and Launch Preparations
Pharvaris has begun building its commercial infrastructure in anticipation of a successful launch. If approved, the company aims to deliver injectable-like efficacy with the convenience of an oral on-demand therapy.
