Rytelo (imetelstat)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- imetelstat
- Company
- Geron Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Anemia; Myelodysplastic Syndromes
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Fri 07 Mar 2025
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006105
- ATC
- L01XX80
- Official record
- www.ema.europa.eu
Indication
Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
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.