Pharvaris Announces FDA Acceptance of New Drug Application for Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks
Pharvaris announced that the FDA has accepted its New Drug Application for deucrictibant IR for the on-demand treatment of Hereditary Angioedema attacks, setting a PDUFA action date of April 23, 2027. The application includes data from the pivotal RAPIDe-3 Phase 3 study, which met all primary and secondary endpoints and demonstrated rapid symptom relief with a median onset time of 1.28 hours.
Key figures
- Drug Name
- deucrictibant IR
- Phase Of Trial
- Phase 3
- Pdufa date
- April 23, 2027
- Attacks treated
- 1300
- Time to symptom relief hours
- 1.28
- Time to complete resolution hours
- 11.95
- Time to end of progression minutes
- 17.48
AI analysis
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