KalVista Pharmaceuticals recently achieved a significant milestone in the healthcare sector. The Japanese Ministry of Health, Labour and Welfare approved EKTERLY (sebetralstat) for the treatment of acute HAE attacks in adults and adolescents aged 12 years and older. This drug serves as an on-demand treatment for hereditary angioedema, also known as HAE. It is the first and only oral on-demand option in Japan. This approval offers a new oral option for managing acute HAE attacks.
Patients with HAE often experience sudden and severe swelling. In the past, many treatments involved painful injections or infusions. Now, KalVista Pharmaceuticals offers a simple tablet for these patients. This oral film-coated tablet demonstrated rapid symptom relief compared to placebo in clinical studies. Early treatment is crucial to stop symptoms from turning life-threatening.
The approval was based on data from the KONFIDENT phase 3 trial. The study demonstrated rapid symptom relief and a favorable clinical profile. Patients treated with EKTERLY (sebetralstat) experienced significant symptom relief compared to placebo. KalVista Pharmaceuticals will commercialize the drug in Japan through its partner, Kaken Pharmaceutical Co., Ltd.
Ben Palleiko, Chief Executive Officer of KalVista, stated:
“The approval of EKTERLY in Japan is a landmark moment for the HAE community and for KalVista. As the first and only oral, on-demand treatment approved in Japan, EKTERLY has the potential to transform the standard of care by providing patients with a discrete and needle-free option to treat their attacks early.”
This approval follows recent authorizations in other major global regions. The drug is already approved in the United States, the United Kingdom, and the European Union. This global expansion underscores KalVista’s efforts to bring the first oral on-demand treatment for HAE to patients worldwide. They aim to improve the lives of people with rare diseases. KalVista stated that EKTERLY has the potential to transform the standard of care for on-demand HAE treatment.
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News Source: Businesswire.com
