India, July 6 -- Biopharmaceutical company Pharvaris N.V. (PHVS) announced Monday 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 (ODT) of Hereditary Angioedema (HAE) attacks.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027.
Pharvaris' NDA details a comprehensive clinical development program for deucrictibant IR, including data from the treatment of over 1,300 HAE attacks.
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In clinical studies, treatment of HAE attacks with deucrictibant IR resulted in rapid time to onset of sympto...