FDA Grants Fast Track Designation To Luspatercept For Treating Lower-risk MDS

(RTTNews) - Celgene Corp. (CELG) and Acceleron Pharma Inc. (XLRN) said that the U.S. Food and Drug Administration has granted Fast Track Designation to luspatercept for the treatment of anemia in patients with lower-risk myelodysplastic syndromes or MDS.

The FDA's Fast Track program 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.

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.