The European Commission (EC) has granted full Marketing Authorization for Reblozyl (luspatercept), for treatment in adult patients of anemia associated with non-transfusion-dependent (NTD) beta thalassemia, US pharma major Bristol Myers Squibb (NYSE: BMY) announced on Friday.
Bristol Myers noted that this represents the third approved indication in Europe for Reblozyl, a first-in-class treatment for patients with diseases impacted by anemia.
The decision was based on results from the Phase II BEYOND study, evaluating the efficacy and safety of Reblozyl versus placebo in 145 adults with NTD beta thalassemia.
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