KalVista Pharmaceuticals, Inc. (KALV) announced FDA approval of EKTERLY, a novel plasma kallikrein inhibitor, for treating acute hereditary angioedema attacks in patients aged 12 and older.
EKTERLY is the first and only oral on-demand treatment for hereditary angioedema.
Prior to EKTERLY, all U.S. on-demand treatments required intravenous or subcutaneous administration, creating a significant treatment burden.
The efficacy and safety of EKTERLY were demonstrated in KalVista Pharmaceuticals’ phase 3 KONFIDENT clinical trial, the largest ever conducted in hereditary angioedema.
Ben Palleiko, CEO of KalVista Pharmaceuticals, called the FDA approval a defining moment for people living with hereditary angioedema.
