Geron Report EMA’s Validation of MAA for Imetelstat to Treat Transfusion-Dependent Anemia in Patients with Lower Risk Myelodysplastic Syndromes
Shots:
- The MAA was based on the P-III trial (IMerge) evaluating imetelstat vs PBO which showed that the 1EPs of 8wk. transfusion independence was higher with imetelstat vs PBO, and median TI duration was 1yr. for imetelstat 8wk. TI responders, mean Hb levels were increased over time vs PBO
- Significant & clinical efficacy results were achieved across MDS subgroups irrespective of ring sideroblast status, baseline transfusion burden & IPSS risk category, PRO data showed a sustained improvement in fatigue
- The MAA is now under CHMP’s review under the centralized procedure valid in all 27 EU member states, Iceland, Norway & Liechtenstein while the review of the MAA is expected to be ~14mos.
Ref: Businesswire | Image: Geron
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