The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals’ Ekterly (sebetralstat) as the first and only oral on-demand medication for acute attacks of hereditary angioedema (HAE) in adults and in children aged 12 years and above.
Ekterly is a 300mg yellow, oval, biconvex film-coated tablet designed for ease of use during an acute attack.
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Its safety and efficacy was demonstrated through data from the company’s Phase III KONFIDENT trial, which showed significant improvements over placebo in terms of symptom relief speed, severity reduction, attack resolution rate and overall tolerability.
KalVista CEO Ben Palleiko stated: “The FDA approval of Ekterly is a defining moment for people living with HAE.
“Ekterly enables people to treat attacks the moment symptoms begin, wherever they are. This approval affirms the strength of our science and deep commitment to the HAE community. Ekterly has the potential to become the foundational treatment for HAE and our focus now is on delivering it to the people who need it.”
The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. It was revealed that patients could initiate treatment with Ekterly within a median time of ten minutes following symptom onset.
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By GlobalDataMoreover, recent data indicates that symptom relief began within approximately 1.3 hours across various types of attacks, including those affecting areas such as the larynx and abdomen.
HAE is a genetic disease characterised by a deficiency or dysfunction of the C1 esterase inhibitor (C1INH) protein, leading to uncontrolled activation of the kallikrein-kinin system.
In April 2025, KalVista Pharmaceuticals granted Kaken Pharmaceutical the commercialisation rights for sebetralstat in Japan.
KalVista will receive an upfront payment of $11m, with an additional $11m contingent upon achieving a regulatory milestone anticipated by early 2026.
