EMA — authorised 7 March 2025
- Application: EMEA/H/C/006105
- Marketing authorisation holder: Geron Netherlands B.V.
- Local brand name: Rytelo
- 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).
- Pathway: orphan
- Status: approved
The EMA has approved Rytelo, a medicinal product developed by Geron Netherlands B.V., for the treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS). This approval was granted under the orphan designation, which is reserved for medicines that treat rare diseases. Rytelo is intended for patients who have failed to respond or have lost response to erythropoiesis-stimulating agents (ESA) or are ineligible for these treatments.