EMA — authorised 17 September 2025
- Application: EMEA/H/C/006211
- Marketing authorisation holder: Kalvista Pharmaceuticals (Ireland) Limited
- Local brand name: Ekterly
- Indication: Ekterly is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
- Pathway: orphan
- Status: approved
On 17 September 2025, the European Medicines Agency (EMA) granted marketing authorisation for Ekterly, a medicinal product for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. This authorisation was granted under the orphan designation, which is reserved for medicines that treat rare diseases. Ekterly is manufactured by Kalvista Pharmaceuticals (Ireland) Limited and will be marketed under the local brand name Ekterly.