BMS’ Reblozyl (luspatercept) Receives EC’s Approval for Anemia in Adult Patients with Non-Transfusion-Dependent Beta Thalassemia
Shots:
- Reblozyl has received full marketing authorization from the EC to treat adult patients with anemia associated with non-transfusion-dependent beta-thalassemia. Reblozyl is being developed & commercialized through a collaboration with Merck
- The approval was based on the P-II study (BEYOND) evaluating Reblozyl vs PBO in a ratio (2:1) in 145 adults. The results showed 77.1% vs 0% of patients achieved the study’s 1EPs, ≥1.0 g/dL mean Hb increase from baseline
- In the 2EPs i.e., 49.0% vs 0% achieved a mean Hb increase of ≥1.5 g/dL over baseline from 37-48 wk. in the absence of transfusions, 89.6% vs 67.3% remained transfusion-free @1-24wk., improvements in patient-reported QoL outcomes were observed to correlate with Hb increases, serious AEs (11.5%)
Ref: BMS | Image: BMS
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
