FDA Approves Label Extension for Reblozyl, Bristol Myers Squibb’s First-Line Anemia Medication

Bristol Myers Squibb disclosed that the FDA has approved Reblozyl (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions. Expansion to the first-line setting was based on positive results from phase three trials.

“Today’s expanded approval of Reblozyl marks an important milestone in our commitment to MDS patients with anemia by providing a durable and more effective treatment option, with more convenient and less frequent administration,” said Wendy Short-Bartie, SVP, general manager, US hematology and cell therapy, Bristol Myers Squibb, in a company press release. “We remain dedicated to addressing hard-to-treat diseases with significant burden to patients and look forward to bringing this important option earlier in the treatment process.”

Reference: U.S. FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions. Bristol Myers Squibb. August 28, 2023. Accessed August 31, 2023. https://news.bms.com/news/corporate-financial/2023/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Reblozyl-luspatercept-aamt-as-First-Line-Treatment-of-Anemia-in-Adults-with-Lower-Risk-Myelodysplastic-Syndromes-MDS-Who-May-Require-Transfusions/default.aspx