KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-demand Treatment for Hereditary Angioedema

KalVista Pharmaceuticals, Inc, today announced the submission of a New Drug Application (NDA) for US Food and Drug Administration (FDA) review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.

If approved, sebetralstat would be the first oral, on-demand therapy for people living with HAE. The NDA filing includes patients aged 12-17 years, whom the Company believes have a particularly high level of unmet need because of the challenges of using injectable medications in that age group.

The Company currently anticipates receiving notification from the FDA on the status of the submission in September. KalVista intends to submit additional marketing authorization applications to other global health authorities throughout 2024.

Ben Palleiko, Chief Executive Officer of KalVista, said: “This NDA submission represents a pivotal moment not only for our company, but for the entire HAE community as we seek to bring an important therapeutic advancement through the first-ever, oral on-demand treatment for HAE. This achievement is the culmination of the entire KalVista team’s long-term efforts, with the critical support of people living with HAE, as well as our partnerships with the HAE scientific community, the HAEA and HAEi patient advocacy organizations, regulators and other stakeholders, that demonstrate our commitment to addressing persistent unmet needs for people living with this rare disease.”

KalVista plans to commence a pediatric trial (KONFIDENT-KID) in Q3 2024 that, if successful, would enable a future filing to extend this coverage to patients aged 2-11 years.

KalVista intends to present additional data from the KONFIDENT and KONFIDENT-S trials at the 2024 Annual Scientific Conference of the American College of Allergy, Asthma, and Immunology (ACAAI) Conference on October 24-28, 2024, in Boston, Massachusetts.

(Source: KalVista)