The U.S. Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals’ new oral drug, Ekterly, the first on-demand pill for treating hereditary angioedema (HAE), a rare and potentially life-threatening swelling disorder.
This approval marks a significant advancement for patients, providing a simpler and more convenient alternative to injectable therapies.
Hereditary angioedema causes sudden swelling in various parts of the body, including the skin, digestive system, and airway, due to a deficiency of a protein called C1 inhibitor. The condition affects approximately 8,000 people in the U.S. and can lead to dangerous, rapid swelling episodes.
Ekterly offers quick symptom relief, with clinical trials showing patients experienced easing of symptoms within 1.6 hours, and some attacks treated in as little as 10 minutes.
Unlike existing treatments that require injections or intravenous administration, this oral medication allows patients to manage attacks more easily and comfortably.
KalVista expects Ekterly to be available by mid-July, with a wholesale cost of about $16,720 per dose, which is comparable to other on-demand therapies priced between $11,000 and $17,000.
The company’s CEO, Ben Palleiko, anticipates strong growth in the U.S. market for on-demand HAE treatments, forecasting a 70% increase by 2030, largely driven by the convenience Ekterly provides.
This approval offers hope for improved quality of life and faster relief for those living with hereditary swelling disorders.
Read more:
