BMS Reports the US FDA Acceptance of sBLA for Priority Review and EMA Validation of Application for Reblozyl (luspatercept-aamt) as 1L Treatment of Anemia
Shots:
- The US FDA has accepted the sBLA of Reblozyl for anemia in adult patients with very low to intermediate-risk myelodysplastic syndromes who may require RBC transfusions. The EMA has validated the Type II variation application for Reblozyl
- The submissions were based on the P-III study (COMMANDS) evaluating Reblozyl vs epoetin alfa in 363 patients which demonstrated a clinical improvement in RBC-TI for ≥12wks. with concurrent Hb increase (≥1.5g/dL). The safety results were consistent with the safety profile of Reblozyl as observed in prior trials & the post-marketing setting
- The results will be presented at upcoming medical meetings. The US FDA has granted Priority Review to the application with an expected PDUFA date of Aug 2023
Ref: BMS | Image: BMS
Related News:- BMS’ Reblozyl (luspatercept) Receives EC’s Approval for Anemia in Adult Patients with Non-Transfusion-Dependent Beta Thalassemia
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