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Bristol Myers Squibb withdraws supplemental biologics license application for Reblozyl for Non-transfusion Dependent (NTD) Beta Thalassemia

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-06-05T17:00:00+05:30  |  Updated On 5 Jun 2022 5:00 PM IST
Bristol Myers Squibb withdraws supplemental biologics license application for Reblozyl for Non-transfusion Dependent (NTD) Beta Thalassemia
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Reblozyl, a first-in-class therapeutic option, is currently approved in the United States, European Union and Canada to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes.

Princeton: Bristol Myers Squibb has announced that the company has withdrawn a supplemental biologics license application (sBLA) for Reblozyl (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.

"The Company could not appropriately address the U.S. Food and Drug Administration's questions about the benefit-risk profile of Reblozyl in this patient population based on the current dataset from the Phase 2 BEYOND trial," the company stated.

"While we will not pursue this indication in the U.S., we're continuing to evaluate Reblozyl in a broad clinical development program to bring this important therapeutic option to more patients living with the burden of anemia," said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb.

Reblozyl, a first-in-class therapeutic option, is currently approved in the United States, European Union and Canada to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes.

BEYOND (NCT03342404) is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept-aamt (ACE-536) versus placebo in adults with non-transfusion dependent beta thalassemia. The study is divided into the screening period, double-blind treatment period (DBTP) and post-treatment follow-up period (PTFP) and randomized 145 subjects at a 2:1 ratio of
Reblozyl
versus placebo. All patients were eligible to receive best supportive care, which included red blood cell transfusions; iron-chelating agents; use of antibiotic, antiviral, and antifungal therapy; and/or nutritional support, as needed. The primary endpoint of the study is the proportion of subjects who have an increase from baseline ≥1.0 g/dL in mean of hemoglobin values over a continuous 12-week interval from Week 13 to Week 24 of treatment in the absence of transfusions. Key secondary endpoints include mean change in non-transfusion dependent beta thalassemia-patient reported outcome (NTDT-PRO) Tiredness and Weakness (TW) domain score and baseline hemoglobin (Hb).
Read also: Bristol Myers Opdivo fails to meet primary endpoint in CheckMate -901 trial
Bristol Myers SquibbBristol Myers Squibb newsReblozylanemiabeta thalassemiaUSFDA
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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