FDA Fast Track for luspatercept for patients with beta-thalassemia

The US Food and Drug Administration has granted Fast Track designations to US biopharma companies Celgene Corp (Nasdaq: CELG) and Acceleron Pharma’s (Nasdaq: XLRN) luspatercept for two separate indications.

These are for the use of luspatercept (previously known as ACE-536) 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 under a 2011 collaboration agreement. Luspatercept is currently in Phase II clinical trials in patients with beta-thalassemia and in patients with myelodysplastic syndromes.

“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 Fouse, president, hematology/oncology for Celgene. “Celgene and Acceleron are working diligently to initiate a Phase III 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,” she added.