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Investing.com -- KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) stock surged 19% after the company announced FDA approval of EKTERLY (sebetralstat), the first and only oral on-demand treatment for hereditary angioedema (HAE).
The approval marks a significant milestone for HAE patients, who previously had to rely exclusively on injectable treatments for acute attacks. EKTERLY is approved for adult and pediatric patients aged 12 years and older, providing an oral option that allows patients to treat attacks immediately when symptoms begin.
"This is an important moment for patients, giving people living with HAE a treatment option that could provide greater independence and control over managing their condition," said Dr. Marc A. Riedl, Professor of Medicine and Clinical Director at the University of California, San Diego’s HAE Center, who served as an investigator for the KONFIDENT phase 3 trial.
The FDA approval was based on results from KalVista’s phase 3 KONFIDENT clinical trial, which demonstrated that EKTERLY achieved significantly faster symptom relief, reduced attack severity, and accelerated attack resolution compared to placebo. The trial, described as the largest ever conducted in HAE, randomized 136 patients across 66 clinical sites in 20 countries.
KalVista plans to launch EKTERLY immediately in the U.S., with physicians able to begin writing prescriptions today. The company has established KalVista Cares, a patient support program offering services including insurance navigation and access support.
HAE is a rare genetic disease characterized by painful and sometimes life-threatening swelling attacks in various parts of the body. Even patients on preventative therapy often experience breakthrough attacks requiring on-demand treatment.
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