Ekterly approved as on-demand therapy for HAE in EU, Switzerland
Approvals of oral swelling treatment follow similar decisions in US, UK
Ekterly (sebetralstat) is now approved by both the European Commission and Swissmedic as an on-demand treatment to manage swelling attacks in people with hereditary angioedema (HAE), ages 12 and older.
These new approvals, which come on the heels of similar approvals in the U.S. and the U.K., cover the 27 member states of the European Union and Switzerland, as well as Iceland, Liechtenstein, and Norway. According to its developer, Kalvista Pharmaceuticals, Ekterly is now the first and only oral on-demand treatment for HAE to be available in these markets.
“The approval of Ekterly in Europe and Switzerland is a significant step forward in our efforts to deliver the first and only oral on-demand treatment for HAE to patients around the world,” Ben Palleiko, CEO of Kalvista, said in a company press release.
Kalvista said it expects to commercially launch Ekterly in Germany later this year and in Switzerland next year, pending finalization of reimbursement plans.
“With our U.S. launch progressing well and approvals now secured in the U.K., [the] EU and Switzerland, we look forward to bringing this innovation to more people living with HAE, beginning with our first European launch in Germany,” Palleiko said. “This continued progress … reinforces the potential of Ekterly to become the foundational treatment for HAE worldwide.”
A genetic disorder, HAE is marked by the overproduction of a signaling molecule called bradykinin, which drives the disease’s characteristic swelling attacks — its hallmark symptom. Before Ekterly’s approval, several on-demand therapies were already available to manage HAE swelling attacks, but they were all given by injection.
Kalvista developed Ekterly as an alternative that can be taken orally, which may be more convenient for some patients. The therapy works to block the activity of kallikrein, an enzyme involved in bradykinin production, thereby reducing bradykinin levels to control swelling.
Ekterly led to faster symptom relief, attack resolution in trial
The therapy’s latest approvals were lauded by Henrik Balle Boysen, president of the advocacy group HAE International.
“As the first orally administered on-demand therapy for HAE attacks, Ekterly provides patients and physicians with an important and welcome new HAE treatment option,” Boysen said.
Approvals of Ekterly have been based largely on data from the global Phase 3 KONFIDENT trial (NCT05259917), which showed that on-demand treatment with Ekterly led to faster symptom relief and attack resolution compared with a placebo. Analyses from the ongoing extension study KONFIDENT-S (NCT05505916) have consistently shown that Ekterly can rapidly ease swelling attacks — including severe ones and those affecting the airways.
Ekterly was generally well tolerated in trials, with the most common medication side effect being headache.
“The KONFIDENT trial showed that Ekterly delivers rapid and reliable symptom relief with a favorable safety profile,” said Danny Cohn, MD, PhD, head of the HAE clinic at Amsterdam University Medical Center and principal investigator for the KONFIDENT trial.
By moving beyond injections, Ekterly introduces a novel approach to managing acute HAE attacks, enabling patients to treat early, discreetly and confidently.
“With [these] approvals, this innovation can now be brought into clinical practice, empowering patients and clinicians across Europe and Switzerland with the first oral on-demand treatment for HAE,” Cohn said. “By moving beyond injections, Ekterly introduces a novel approach to managing acute HAE attacks, enabling patients to treat early, discreetly and confidently.”
A separate Phase 3 clinical trial called KONFIDENT-KID (NCT06467084), which is testing Ekterly in children with HAE ages 2 to 11, is ongoing, with results expected in 2027.
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