Biopharmaceutical company KalVista Pharmaceuticals Inc (Nasdaq: KALV) announced on Monday that it has received U.S. Food and Drug Administration (FDA) approval for EKTERLY (sebetralstat), the first and only oral on-demand treatment for acute attacks of hereditary angioedema (HAE) in patients aged 12 and older.

EKTERLY is the first new on-demand therapy for HAE approved in over a decade, offering a transformative alternative to intravenous or subcutaneous options. Approval was based on the phase 3 KONFIDENT trial, the largest HAE trial to date, which demonstrated rapid symptom relief, attack resolution, and a safety profile comparable to placebo. Real-world data from the open-label KONFIDENT-S extension trial showed a median treatment initiation time of 10 minutes and symptom relief within 1.3 hours for severe attacks.

KalVista is launching EKTERLY immediately in the US, supported by the KalVista Cares patient access program. The company also has multiple regulatory applications under review internationally and is conducting additional trials in children aged two to 11.

Hereditary angioedema is a rare genetic condition marked by unpredictable and potentially life-threatening tissue swelling. EKTERLY's approval addresses a longstanding unmet need for a convenient, fast-acting, oral treatment option.