Xermelo (telotristat ethyl)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- telotristat ethyl
- Company
- SERB SAS
- Status
- Authorised
- Therapeutic area
- Carcinoid Tumor; Neuroendocrine Tumors
- CHMP opinion
- Wed 19 Jul 2017
- EU approval
- Sun 17 Sep 2017
- Designations
- Orphan
- Application
- EMEA/H/C/003937
- ATC
- A16A
- Official record
- www.ema.europa.eu
Indication
Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
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.