Kalvista Pharmaceuticals has secured FDA approval for Ekterly (sebetralstat), an oral therapy to treat hereditary angioedema (HAE) attacks in patients aged 12 and older. After a delayed decision attributed to FDA resource constraints, the drug’s approval marks the first oral on-demand treatment in the U.S., competing with injectable options from Takeda and Pharming. Clinical trials demonstrated rapid symptom relief and a favorable safety profile, with potential peak sales estimated at $600 million annually. Kalvista has also licensed commercialization rights in Canada and Japan, indicating strategic expansion plans.