KalVista Submits New Drug Application For FDA Review Of Sebetralstat

Sebetralstat is a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.

The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review. The Company currently anticipates receiving notification from the FDA on the status of the submission in September. KalVista intends to submit additional marketing authorization applications to other global health authorities throughout 2024.