(CercleFinance.com) – Bristol Myers Squibb has received a positive CHMP opinion for Reblozyl (luspatercept) in adult patients with anemia-associated non-transfusion-dependent beta-thalassemia (ATN).
The recommendation will now be considered by the European Commission (EC). Once approved, this would be the third indication approved for Reblozyl in the EU.
Approval by the European Commission would expand Reblozyl’s indications for the treatment of anemia in adults with beta-thalassemia in Europe.
In the pivotal BEYOND study, Reblozyl significantly increased hemoglobin levels, which were maintained for a longer period compared to placebo.
“The potential approval of Reblozyl for patients with non-transfusion-dependent beta-thalassemia represents an important development in the EU, where several countries have high prevalence and more people are affected by the disease. ‘ said Noah Berkowitz, Vice President, Hematology Development, Bristol Myers Squibb.
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