KalVista wins FDA greenlight for Ekterly
USA and UK-based KalVista Pharmaceuticals (Nasdaq: KALV) today announced that the US Food and Drug Administration (FDA) has approved Ekterly (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
Ekterly is the first and only oral on-demand treatment for HAE, said KalVista, whose shares rose by 26.88% in pre-market trading. The FDA decision comes after a setback last month, when the agency said it will not meet its previously announced decision date of July 17, due to heavy workload and limited resources.
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