FDA Delays sBLA Decision Date on Bristol Myers Squibb Anemia Drug Reblozyl

The FDA has pushed back its decision date on Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt) for the treatment of patients with nontransfusion dependent beta thalassemia anemia by three months to June 27.

The sBLA submission was based on a phase 2 study in 145 patients that demonstrated a “meaningful difference” in mean hemoglobin concentration in those who received the drug compared with those given placebo.

BMS said the agency asked for additional information before making a decision on the sBLA.

Reblozyl is currently FDA-approved for patients with anemia with beta thalassemia who need regular blood transfusions and certain patients with very low-to-intermediate risk myelodysplastic syndrome who have anemia that did not respond to an erythropoiesis stimulating agent.