KalVista receives FDA approval for EKTERLY (sebetralstat), first oral on-demand HAE treatment

KalVista Pharmaceuticals, Inc.

FDA approved EKTERLY for acute attacks of hereditary angioedema in patients 12+ years; first oral on-demand therapy.
Phase 3 KONFIDENT trial (136 patients, 20 countries) showed faster symptom relief vs placebo; published in NEJM.
KONFIDENT-S open-label extension: median 10 minutes to treat attacks after onset; 1.3 hours to symptom relief for laryngeal/abdominal/breakthrough attacks.
Launching immediately; prescriptions available today; KalVista Cares patient support program launched.
CEO Ben Palleiko says EKTERLY has potential to become foundational HAE treatment; conference call at 8:30am ET.

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