KalVista's Sebetralstat NDA Accepted by FDA, Could Be First Oral On-Demand HAE Treatment by Mid-2025

Author: Benzinga Newsdesk | September 03, 2024 06:32am

KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025. If approved, sebetralstat would be the first oral, on-demand treatment for HAE in adult and pediatric patients aged 12 years and older. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.

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