KalVista Announces the Submission of Additional Marketing Authorization Applications for Sebetralstat for the Oral On-Demand Treatment of Hereditary Angioedema

– Submissions support KalVista’s mission of building a global footprint for sebetralstat to address the significant unmet need for people with HAE worldwide –

– If approved, sebetralstat will be the first, oral on-demand treatment for HAE –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) today announced Marketing Authorization Application (MAA) submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. The four MAAs have been submitted via the Access Consortium framework for which KalVista has obtained a four-way work-sharing agreement by the Medicines and Healthcare product Regulatory Agency, Swissmedic, the Therapeutic Goods Administration and Health Sciences Authority. The Access Consortium is designed to maximize regulatory collaboration across countries and support a timely review process.

“Today’s news, which comes only a few weeks following our announcements regarding our U.S. FDA PDUFA date of June 17 and validation of our MAA by EMA, further underscores our focus and dedication to getting sebetralstat to as many people living with HAE as possible,” said Ben Palleiko, CEO of KalVista. “To serve that goal, we are building a global commercial presence to provide the greatest possible access to potentially the first oral on-demand treatment for this debilitating disease. I am proud of the KalVista team for their dedication and continued hard work submitting these additional MAAs.”

The MAA submissions are supported by previously disclosed results, including data from the KONFIDENT phase 3 clinical trial and ongoing KONFIDENT-S open label extension trial. Sebetralstat met the primary endpoint for its phase 3 trial with both 300 mg and 600 mg formulations achieving the beginning of symptom relief significantly faster than placebo (p