Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS
Shots:
- The EC has approved Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy in 30 EEA states; commercialization to begin in select EU states by 2026 pending country-by-country reimbursement
- Approval was based on P-III (IMerge) study of Rytelo vs PBO that showed reduced need for RBC transfusions within the first 24wks., along with favorable safety
- The COMP has recommended to maintain Rytelo’s ODD in the EU for MDS, with patent exclusivity potentially extending to 2038 pending approval. Also, Geron is exploring EAP, incl. NPP to enhance pts access to Rytelo
Ref: Businesswire | Image: Geron
Related News:- Geron Receives Positive CHMP Opinion for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
