(News Bulletin 247) – Bristol Myers Squibb announced yesterday that the Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application (sBLA) for Reblozyl.
This therapeutic option is used in the treatment of anemia without prior use of erythropoiesis-stimulating agents in adult patients with very low or intermediate risk myelodysplastic syndromes.
The European Medicines Agency (EMA), for its part, validated the type II modification request for Reblozyl.
In the United States, the FDA granted the application priority review and assigned a deadline of August 28, 2023. The priority review designation underscores the importance of unmet need and the value that Reblozyl could bring to this patient population.
In Europe, EMA validation of the application confirms that the submission is complete and begins the EMA’s centralized review process.
“Reblozyl is an important option for the treatment of anemia in patients with low-risk, transfusion-dependent MDS,” said Noah Berkowitz, MD, Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb.
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