The EMA’s CHMP has adopted a positive opinion recommending approval of Reblozyl for anemia associated with NTD beta-thalassemia. The EC’s decision is expected within 67 days & will apply to all EU member states, Iceland, Norway & Liechtenstein
The opinion was based on the P-II study (BEYOND) results evaluating Reblozyl vs PBO in a ratio (2:1) in 145 adults. Reblozyl is being developed & commercialized by Merck
The results showed that 77.1% achieved the 1EPs of the study & ≥1.0 g/dL mean Hb increase from baseline. In the 2EPs, 49.0% vs 0% achieved a mean Hb increase of ≥1.5 g/dL over baseline from 37-48wk. in the absence of transfusions, transfusion free (89.6% vs 67.3%) @ 1-24wk., improvements in patient-reported QoL outcomes, serious adverse reactions (11.5% vs 25%)
Ref: BMS | Image: BMS
Related Post: BMS Reports P-III (COMMANDS) Study Results of Reblozyl (luspatercept-aamt) for Myelodysplastic Syndromes
