The P-III study evaluating Reblozyl vs epoetin alfa for anemia in 363 adult patients with very low, low, or intermediate-risk MDS who require RBC transfusions & are ESA-naïve with median treatment durations of 41.6 & 27wks.
58.5% vs 31.2% achieved the 1EPs of RBC-TI of 12wks. with Hb increase of 1.5g/dL within the first 24wks.; HI-E increase (74.1% vs 51.3%) @8wks. along with more durable responses with a m-DoR of RBC-TI ≥12wks. (126.6 vs 77wks.); RBC-TI (47.6% vs 29.2%) within the first 24wks., Benefits were observed in clinically relevant subgroups and showed a consistent safety profile with no new safety signals
The sBLA of Reblozyl is currently under the US FDA’s Priority Review for the same indication & the PDUFA date is expected in Aug 2023
Ref: BMS | Image: BMS
Related News:- BMS Reports P-II Study Results of BMS-986278 for the Treatment of Idiopathic Pulmonary Fibrosis
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
