Bristol Myers, Merck anemia therapy undergoes U.S. and EU review for label expansion

• Bristol Myers Squibb (NYSE:BMY) announced Monday that the U.S. and EU regulators have agreed to review a request for a potential label expansion for its anemia therapy Reblozyl, being developed with Merck (NYSE:MRK).
• Reblozyl is currently indicated in the U.S. for anemia in adults with beta-thalassemia who require regular red blood cell (RBC) transfusions and certain patients with myelodysplastic syndromes who require two or more red blood cell units over eight weeks.
• The new marketing requests are targeted at adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require RBC transfusions.
• The marketing applications are backed by data from the Phase 3 COMMANDS trial, which indicated independence from RBC transfusion after Reblozyl therapy as a first-line option in adults with very low-, low- or intermediate-risk MDS who require RBC transfusions.
• The FDA has granted the company’s supplemental Biologics License Application (sBLA) Priority Review with a regulatory action date on August 28, 2023.

More on Reblozyl

• EC approves Bristol Myers' Reblozyl for anemia due to beta thalassemia
• Bristol-Myers Squibb withdraws sBLA for Reblozyl in non-transfusion beta thalassemia