European Commission approves REBLOZYL® for β-thalassaemia

REBLOZYL® (Luspatercept) has been approved by the European Commission for the treatment of transfusion-dependent anaemia in adult patients with beta-thalassaemia and myelodysplastic syndromes (MDS). Originally developed by Acceleron as ACE-536 and licensed by Celgene (now part of US pharma major Bristol-Myers Squibb) in 2011, REBLOZYL® was approved by the FDA for anaemia associated with beta thalassaemia last year. The approval for REBLOZYL® is based on positive data from the BELIEVE (beta-thalassaemia) and phase III MEDALIST (MDS) studies. This is the first and only erythroid maturation agent to be approved in the European Union, which, for the first time, will help decrease the number of blood transfusions and consequent iron-induced dysfunction by decreasing the iron-loading burden. For more information, see here.