Following an unexpected regulatory delay last month, KalVista Pharmaceuticals has officially entered the commercial market with the FDA approval of its plasma kallikrein inhibitor, sebetralstat. On July 7, 2025, the FDA cleared sebetralstat, now branded as EKTERLY, as an oral treatment for acute hereditary angioedema (HAE) attacks in patients aged 12 and older. EKTERLY becomes the first and only oral, on-demand therapy available for HAE. This approval came shortly after the agency missed its initial target decision date of June 17.
Sebetralstat received Fast Track and Orphan Drug Designations from the US FDA, as well as Orphan Drug Designation and an approved Pedia...
