Bristol Myers Squibb gets Reblozyl EC approval for anemia associated with NTD beta thalassemia

Bristol Myers Squibb (BMY) has secured full marketing authorization for Reblozyl (luspatercept) from the European Commission (EC) for treating anemia associated with non-transfusion-dependent (NTD) beta thalassemia in adult patients.

Presently, Reblozyl is approved in the European Union (EU), the US, and Canada for addressing anemia resulting from transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes.

The EC’s central marketing authorization approves the use of Reblozyl across each of the EU member states along with Norway, Liechtenstein, and Iceland.

The Reblozyl EC approval is based upon the findings of the BEYOND phase 2 study that evaluated the drug candidate’s effectiveness and safety as compared to placebo in 145 patients suffering from NTD beta Thalassemia.Bristol Myers Squibb

Patients enrolled in the trial could receive the best care for their condition, including red blood cell transfusions as well as iron-chelating agents.

Bristol Myers Squibb gets Reblozyl EC approval for anemia associated with NTD beta thalassemia. Bristol-Myers Squibb Company

Noah Berkowitz — Bristol Myers Squibb senior vice president of Hematology Development said: “Beta thalassemia is an inherited blood disorder that puts patients at significant risk for long-term clinical complications due to anemia, leaving a substantial need for treatment options, regardless of a patient’s dependence on blood transfusions.

“This announcement is welcome news for patients with non-transfusion-dependent beta thalassemia associated anemia across the EU who are seeking newer treatment options to reduce these burdens.

“Today’s approval represents the third indication for Reblozyl in Europe, and we look forward to continuing to evaluate this first-in-class therapeutic option across multiple diseases impacted by the burden of anemia in a broad clinical development program.”

Reblozyl is currently being developed and commercialized by Bristol Myers Squibb in an international collaboration with Merck. This was after Merck’s acquisition of Acceleron Pharma in 2021.