Celgene Corporation and Acceleron Pharma Inc. today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designations to luspatercept for two separate indications; the use of luspatercept for the treatment of patients with transfusion dependent beta-thalassemia and the use of luspatercept for the treatment of patients with non-transfusion dependent beta-thalassemia. Celgene and Acceleron are jointly developing luspatercept.

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. The designation also provides the opportunity for more frequent interaction with FDA over the course of the development program, and allows a sponsor to submit sections of the BLA on a rolling basis as they are finalized.

“The FDA’s Fast Track designation for the luspatercept development program recognizes the serious unmet medical needs of patients with beta-thalassemia and the potential for luspatercept in this area,” said Jacqualyn A. Fouse, President, Hematology/Oncology for Celgene. “Celgene and Acceleron are working diligently to initiate a phase 3 clinical program in 2015 to treat patients with beta-thalassemia and we look forward to continuing to work closely with health authorities and other important stakeholders to advance this program.

For more details, go to: http://www.businesswire.com/news/home/20150518005252/en/FDA-Fast-Track-Designation-Granted-Luspatercept-Treatment#.VVpcamC21Vs