KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-Demand Treatment for Hereditary Angioedema

KalVista submits NDA to FDA for sebetralstat, an oral on-demand treatment for HAE, based on phase 3 trial results showing faster symptom relief than placebo. The drug is well-tolerated with no treatment-related SAEs. FDA has a 60-day review period, with potential approval leading to the first oral on-demand HAE therapy.