Sebetralstat FDA Approval Status
Last updated by Judith Stewart, BPharm on July 22, 2024.
FDA Approved: No
Generic name: sebetralstat
Company: KalVista Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema
Sebetralstat is an oral plasma kallikrein inhibitor in development for the on-demand treatment of hereditary angioedema attacks in adults and pediatric patients aged 12 years and older.
- Hereditary angioedema (HAE) is a genetic disease characterized by a deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. Symptoms of an HAE attack include painful and debilitating attacks of tissue swelling in the hands, feet, limbs, face, intestinal tract, and airways.
- Sebetralstat works in the treatment of HAE by targeting the kallikrein-kinin system (KKS) cascade and selectively inhibiting plasma kallikrein which drives HAE attacks. Sebetralstat is administered orally to readily treat HAE attacks on-demand, including at the earliest signs before the HAE attack fully develops. All currently approved on-demand treatment options require either intravenous or subcutaneous administration.
- A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for review of sebetralstat based on clinical trial results, including data from the KONFIDENT phase 3 clinical trial and the KONFIDENT-S extension trial. Sebetralstat met the primary endpoint in the phase 3 trial with both 300 mg and 600 mg formulations achieving the beginning of symptom relief significantly faster than placebo. The median time to beginning of symptom relief was 1.61 hours with sebetralstat 300 mg, 1.79 hours with sebetralstat 600 mg and 6.72 hours with placebo.
- In clinical studies, sebetralstat was shown to be well-tolerated, with a safety profile no different than placebo and no treatment-related serious adverse events. This favorable safety profile has been consistently observed in all clinical studies for sebetralstat to date.
Development timeline for sebetralstat
Further information
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