Celgene Corporation and Acceleron Pharma Inc. have announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to luspatercept for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS). The Fast Track program of the FDA is designed to facilitate the development, and expedite the review, of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Celgene and Acceleron are developing luspatercept to treat patients with rare blood disorders, including MDS and beta-thalassemia. For people with MDS, a type of blood cancer, anemia is a challenging clinical complication of the disease. Patients receive chronic red blood cell transfusions as standard of care to manage the anemia. Luspatercept is designed to increase red blood cell levels in a way that is fundamentally distinct from existing therapies, and has the potential to treat anemia in patients whose disease is not adequately addressed by the treatments available today.
“The FDA’s Fast Track Designation for luspatercept recognizes the serious unmet medical needs of patients with MDS,” said Jacqualyn A. Fouse, President, Hematology/Oncology for Celgene. “Celgene and Acceleron are working to initiate a Phase 3 clinical program to investigate the treatment of patients with low- and intermediate- risk MDS before the end of the year.”
The companies previously announced FDA Fast Track Designation for luspatercept to treat beta-thalassemia.