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"First-in-class" anemia therapy received FDA priority review qualification

 Last Update: 2021-12-31
 Source: Internet
 Author: User

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Recently, Celgene, a subsidiary of Bristol-Myers Squibb (BMS), announced that the US FDA has granted priority review for the supplementary biological product license application (sBLA) for the "first-in-class" red blood cell maturation agent Reblozyl (luspatercept-aamt) Qualified for the treatment of adult patients with transfusion-independent β-thalassemia

Beta thalassemia is an inherited blood disease, it is one of the most common autosomal recessive inherited diseases

Reblozyl is an innovative drug that reduces the burden of blood transfusion by regulating the red blood cell maturation process in the later stage

▲Reblozyl can increase the hemoglobin content in the blood of patients and increase the differentiation of mature red blood cells (picture source: reblozyl.

This application is based on the positive results obtained in a pivotal phase 2 clinical trial.

Reference materials:

[1] US Food and Drug Administration Accepts for Priority Review supplemental Biologics License Application for Reblozyl® (luspatercept-aamt) in Adults with Non-Transfusion Dependent (NTD) Beta Thalassemia.

[2] Bristol Myers Squibb and Acceleron Present First Results from Phase 2 BEYOND Study of Reblozyl® (luspatercept-aamt) in Adults with Non-Transfusion Dependent(NTD) Beta Thalassemia.

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