European Commission Grants Marketing Authorization to Luspatercept

The European Commission (EC) has granted full Marketing Authorization to luspatercept for the treatment of anemia in adult patients with nontransfusion-dependent beta thalassemia.

The centralized Marketing Authorization approves use of luspatercept in all European Union (EU) member states, as well as Norway, Iceland, and Liechtenstein.

Luspatercept is currently approved in the EU, United States, and Canada to address anemia associated with transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes.

The EC approval of luspatercept was based on results from the phase II BEYOND study, evaluating the efficacy and safety of the drug versus placebo in 145 adults with nontransfusion-dependent beta thalassemia. Patients were eligible to receive best supportive care, including red blood cell transfusions and iron-chelating agents.

Source: Bristol Myers Squibb, March 2023