USFDAJul 6, 2026, 06:51 AM
Pharvaris FDA Accepts NDA for Deucrictibant; PDUFA Date April 23, 2027
AI Summary
Pharvaris announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of Hereditary Angioedema (HAE) attacks. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027. If approved, deucrictibant will be the first oral bradykinin B2 receptor antagonist to treat HAE attacks, with the NDA including positive data from a successful clinical program demonstrating rapid relief and sustained response.
Key Highlights
- FDA accepted the New Drug Application (NDA) for deucrictibant immediate-release (IR) capsule (20 mg).
- PDUFA target action date for deucrictibant is set for April 23, 2027.
- Deucrictibant is for the on-demand treatment of Hereditary Angioedema (HAE) attacks.
- If approved, deucrictibant will be the first oral bradykinin B2 receptor antagonist for HAE.
- RAPIDe-3 Phase 3 study met primary and all 11 secondary efficacy endpoints with statistical significance.
- Median time to onset of symptom relief was 1.28 hours in clinical studies.
- Median time to complete resolution of HAE attack symptoms was 11.95 hours.
- Deucrictibant was granted orphan drug designation by the FDA in 2022.
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