11:17 AM EDT, 06/18/2024 (MT Newswires) -- KalVista Pharmaceuticals ( KALV ) said Tuesday it submitted a new drug application to the US Food and Drug Administration for its investigational sebetralstat therapy for hereditary angioedema attacks in adults and pediatric patients aged 12 years and above.

Sebetralstat met the primary endpoint in a phase 3 trial with both 300 mg and 600 mg formulations achieving the beginning of symptom relief "significantly faster" than placebo, the company said. The company observed a favorable safety profile in all clinical studies for sebetralstat so far.

KalVista said it expects to receive notification from the FDA on the status of the submission in September, and the company plans to submit additional marketing authorization applications to other global health authorities through 2024.

KalVista intends to begin a pediatric trial in Q3.

Hereditary angioedema is a rare and potentially life-threatening genetic condition that involves recurrent attacks of severe swelling in various body parts.

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