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BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)

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BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)

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  • The positive opinion was supported by the P-III (COMMANDS) study assessing the safety & efficacy of Reblozyl (1.0mg/kg, titration ~1.75mg/kg, Q3W) vs epoetin alfa (450 IU/kg, titration ~1050IU/kg, QW) for ≥24 wks. to treat transfusion-dependent anemia due to very low-, low- or intermediate-risk (IPSS-R) MDS in patients naïve to erythropoiesis-stimulating agent
  • The data, as of Mar 2023, in patients (n=363) depicted RBC-TI of at least 12wks. in 60.4% vs 34.8% with mean Hb increase of ~1.5 g/dL in first 24wks., 74.2% vs 53% had HI-E increase of at least 8wks., 68.1% vs 48.6% experienced RBC-TI of at least 12wks.& a DoR of 128.1wks. vs 89.7wks.
  • The safety profile was consistent with the prior MDS programs

Ref: BMS | Image: BMS

Related News:- BMS’ Reblozyl (luspatercept-aamt) Receives the US FDA’s Approval as 1L Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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