KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema
KalVista Pharmaceuticals announced the FDA accepted its New Drug Application for sebetralstat, an oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE) attacks in patients aged 12 and older, with a PDUFA goal date of June 17, 2025. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE. The NDA was supported by data from the KONFIDENT phase 3 trial and ongoing KONFIDENT-S extension trial, showing significant symptom relief and good tolerability. KalVista also initiated the KONFIDENT-KID trial for pediatric patients aged 2-11 and expects to file for approval in the UK, Japan, and other countries in 2024.
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KalVista Pharmaceuticals announced the FDA accepted its New Drug Application for sebetralstat, an oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE) attacks in patients aged 12 and older, with a PDUFA goal date of June 17, 2025. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE. The NDA was supported by data from the KONFIDENT phase 3 trial and ongoing KONFIDENT-S extension trial, showing significant symptom relief and good tolerability. KalVista also initiated the KONFIDENT-KID trial for pediatric patients aged 2-11 and expects to file for approval in the UK, Japan, and other countries in 2024.