Celgene’s Reblozyl Earns FDA Approval for Anemia

Celgene’s Reblozyl (luspatercept-aamt) earned FDA approval for treatment of anemia in adults with very low-risk to intermediate-risk myelodysplastic syndromes (MDS) — a group of cancers in which immature blood cells in the bone marrow do not mature into healthy blood cells.

The approval marks the second indication for Reblozyl. The drug received its first approval in November 2019 for the treatment of anemia in adults with beta thalassemia who require regular red blood cell transfusions.

The approval makes Reblozyl the first approved treatment for patients with MDS in 15 years. The drug received both fast-track and orphan drug designation for the indication.