Pharvaris has announced that the U.S. FDA has accepted its NDA for deucrictibant IR capsules to treat hereditary angioedema (HAE) attacks, with a PDUFA action date set for April 23, 2027.
Deucrictibant is a novel, oral bradykinin B2 receptor antagonist that received orphan drug designation from the FDA in 2022. If approved, it will become the first such drug to treat HAE attacks. The acceptance of its NDA is based on a clinical trial of patients aged 12 years and above, including those with a normal C1 inhibitor. In the trial, the drug showed fast relief, with a median time to onset of symptom relief of 1.28 hours, and a sustained response, with complete resolution of symptoms in 11.95 hours. It was also well tolerated.
The news follows FDA approval for Ekterly, a novel plasma kaillikrein inhibitor from KalVista Pharmaceuticals, which also treats acute attacks of HAE. KalVista has said that it will be launching Ekterly in the U.S. immediately and that physicians can now begin writing prescriptions.