KalVista Seeks FDA OK of Sebetralstat for Hereditary-Angioedema Attacks

By Colin Kellaher

KalVista Pharmaceuticals has filed for Food and Drug Administration approval of sebetralstat, a proposed oral on-demand treatment for hereditary-angioedema attacks in people ages 12 and older.

KalVista on Tuesday said the filing is based on studies in which sebetralstat achieved the beginnings of symptom relief significantly faster than a placebo in patients with the rare genetic disease that can cause painful and debilitating attacks of tissue swelling in various parts of the body.

The Cambridge, Mass., pharmaceutical company noted that all currently approved on-demand treatment options for hereditary-angioedema attacks require either intravenous or subcutaneous administration.

KalVista said the FDA has a 60-day review period to determine whether the filing is complete and accepted for review, adding that it plans file applications with other global health authorities throughout 2024.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 18, 2024 06:57 ET (10:57 GMT)

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