FDA Approves REBLOZYL® for Treatment of Anemia in Adults with Beta Thalassemia

November 8, 2019 – The FDA has approved REBLOZYL® (luspatercept-aamt) for the treatment of anemia in adults with beta thalassemia who require regular red blood cell transfusions. REBLOZYL® is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy which works by regulating late-stage red blood cell maturation to help patients reduce their red blood cell transfusion burden.

The approval of REBLOZYL® for beta thalassemia is based on results from the pivotal Phase 3 BELIEVE trial, in which 21.4% of patients treated with REBLOZYL® achieved a ≥33% reduction from baseline in red blood cell transfusion burden (with a reduction of at least 2 units) during weeks 13–24 after randomization, compared to 4.5% of patients in the placebo arm.

In the BELIEVE trial, thromboembolic events, including deep vein thromboses, pulmonary embolus, portal vein thrombosis, and ischemic stroke, were experienced in 3.6% of REBLOZYL®-treated patients. Hypertension was reported in 10.7% of REBLOZYL®-treated patients.

Further information can be found in the following press release: https://ir.celgene.com/press-releases/press-release-details/2019/FDA-Approves-REBLOZYL-luspatercept-aamt-for-the-Treatment-of-Anemia-in-Adults-With-Beta-Thalassemia-Who-Require-Regular-Red-Blood-Cell-Transfusions/default.aspx

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