CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:KALV) announced that the European Medicines Agency (EMA) has begun reviewing its Marketing Authorization Application (MAA) for sebetralstat.
This oral medication is a candidate for the on-demand treatment of hereditary angioedema (HAE), a rare genetic disease characterized by spontaneous swelling attacks.
The validation of the MAA indicates progress towards introducing sebetralstat to the European market, which is pending approval. Sebetralstat could become the first oral on-demand treatment for HAE in Europe. Ben Palleiko, CEO of KalVista, expressed optimism about the drug's potential to address unmet needs within the HAE community.
The submission is supported by data from the KONFIDENT phase 3 trial, which reported that sebetralstat significantly reduced the time to symptom relief compared to placebo.
The trial included adult and pediatric patients aged 12 years and older. Results from the trial have been published in The New England Journal of Medicine and were presented at the European Academy of Allergy and Clinical Immunology Congress 2024.
KalVista also submitted a New Drug Application (NDA) for sebetralstat to the U.S. Food & Drug Administration in June 2024. Further, the company plans to present additional data from the KONFIDENT trial in the EU at the upcoming 7th Bradykinin Symposium in Berlin, Germany, from September 4-6, 2024.
In addition to the KONFIDENT trial, KalVista has launched the KONFIDENT-KID trial to evaluate the drug's safety and efficacy in children aged 2-11 years. If approved, sebetralstat would be the first oral therapy for this age group, offering a new treatment option for pediatric HAE patients.
Sebetralstat has garnered Fast Track and Orphan Drug Designations from the U.S. FDA and Orphan Drug Designation from the EMA. All currently approved on-demand treatments for HAE require either intravenous or subcutaneous administration, highlighting the potential impact of an oral treatment option.
This news is based on a press release statement from KalVista Pharmaceuticals, Inc. and reflects the company's current expectations regarding the approval and potential benefits of sebetralstat.
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