Celgene and Acceleration Pharma Announce Submission of Luspatercept Biologics License Application to FDA

Celgene (NASDAQ:CELG) and Acceleron Pharma (NASDAQ:XLRN) have announced that Celegene has submitted a biologics license application for luspatercept, which is to treat adult patients with low to intermediate risk myelodysplastic syndromes with ring sideroblasts and need red blood cell transfusions, and for treatment of patients with beta thalassemia-associated anemia that require red blood cell transfusions.

As quoted in the press release:

The submission is based on the safety and efficacy results of the pivotal phase 3 studies MEDALIST and BELIEVE, both recently presented at the American Society of Hematology annual meeting, where MEDALIST was included in the plenary session.

“There remains a high unmet medical need for patients with MDS or beta-thalassemia who suffer from the effects of their disease-related anemia. The primary treatment option for these patients currently is chronic transfusion of red blood cells which can be associated with complications such as iron overload,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “New treatment options are urgently needed for these patients. With this submission, we look forward to working with the Agency to deliver luspatercept to patients with these serious blood diseases.”

The companies also plan to submit a marketing application to the European Medicines Agency in the second quarter of 2019.

Click here to read the full press release.