FDA Approval for Celgene and Acceleron Drug REBLOZYL®
The U.S. Food and Drug Administration (FDA) has approved Celgene’s (CELG) and Acceleron Pharma’s (XLRN) drug REBLOZYL® (luspatercept-aamt) for anemia only in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
REBLOZYL® is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy that works by regulating late-stage red blood cell maturation to help patients reduce their RBC transfusion burden.
Comments from Celgene & Acceleron
Explaining the importance of REBLOZYL® approval, Nadim Ahmed, President, Global Hematology and Oncology for Celgene said, “… “There are very limited options for patients living with anemia due to beta-thalassemia who are dependent on long term red blood cell transfusions. REBLOZYL®is now available as a new therapy for these patients to help address their anemia, a significant clinical complication of beta-thalassemia.”
Habib Dable, President and Chief Executive Officer of Acceleron stated, “We’re thrilled that Acceleron’s first approved medicine is one with the potential to help patients with beta-thalassemia, who have been in need of new treatments for this lifelong disease…”
Treatment options for anemia associated with beta-thalassemia are limited, consisting mainly of RBC transfusions, which have the potential to contribute to iron overload that can cause serious complications such as organ damage.