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The US FDA has accepted NDA for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of Hereditary Angioedema (HAE) attacks (PDUFA: Apr 23, 2027)
NDA was backed by data from >1,300 HAE attacks. In P-III (RAPIDe-3) trial, deucrictibant IR met the 1EP & all eleven 2EPs, with median times to symptom relief, End of Progression, & complete resolution of attack symptoms were 1.28 hrs, 17.48mins, & 11.95 hrs, respectively
Deucrictibant is an oral small-molecule bradykinin B2 receptor antagonist in clinical development, being assessed as both an extended-release tablet for prophylaxis and an immediate-release capsule for on-demand treatment
Ref: Globenewswire | Image: Pharvaris | Press Release
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The post Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks appeared first on PharmaShots.
Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks | PharmaVoice