Ekterly (sebetralstat)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- sebetralstat
- Company
- Kalvista Pharmaceuticals (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Angioedemas, Hereditary
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 17 Sep 2025
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006211
- ATC
- B06AC08
- Official record
- www.ema.europa.eu
Indication
Ekterly is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.