The European Union (EU) authorities have agreed to review Kalvista Pharmaceuticals’ application for approval of oral sebetralstat as an on-demand treatment for swelling attacks in patients with hereditary angioedema (HAE).
The company’s Marketing Authorization Application (MAA) will now be reviewed by a committee of the European Medicines Agency for all 27 EU member states as well as Norway, Iceland and Liechtenstein.
“The validation of this MAA, which we submitted in July, brings us another step closer to our goal of distributing sebetralstat to people with HAE worldwide,” said Ben Palleiko, CEO of Kalvista, in a company press release.
After the therapy was applied in clinical trials, the swelling attacks were quickly alleviated
“If approved, sebetralstat would be the first oral, on-demand treatment for HAE in Europe,” added Palleiko. “We believe it has the potential to become the foundational treatment for this disease and address many fundamental unmet needs in the population.”
Kalvista recently submitted an application to U.S. regulators seeking approval of sebetralstat as an on-demand treatment for HAE patients ages 12 and older. The company said it will submit similar applications to regulators in other countries, including the United Kingdom and Japan, later this year.
The swelling attacks typical of HAE are caused by mutations that lead to overproduction of a signaling molecule called bradykinin. Sebetralstat is designed to block the activity of kallikrein, the enzyme that mediates the production of bradykinin. By blocking kallikrein, sebetralstat is designed to lower bradykinin levels and ultimately control swelling.
There are other treatments available for on-demand treatment of HAE attacks, but they are all given as injections. Sebetralstat is poised to become the first oral on-demand treatment for HAE swelling attacks.
Kalvista’s regulatory submissions were based primarily on data from the Phase 3 KONFIDENT clinical trial (NCT05259917) and the KONFIDENT-S extension study (NCT05505916). In these studies, sebetralstat was tested in HAE patients aged 12 years and older. Results showed that most patients experienced relief of symptoms less than two hours after receiving oral therapy.
Kalvista recently initiated a separate clinical trial called KONFIDENT-KID (NCT06467084) of sebetralstat as an on-demand treatment for children with HAE ages 2 to 11 years. This trial is actively recruiting patients at six sites in the United States and is open to children with HAE type 1 or 2 who have had at least one swelling attack in the past year.
