Celgene Receives FDA Approval for REBLOZYL

Celgene (NASDAQ:CELG) and Acceleron Pharma (NASDAQ:XLRN) have announced that the US Food and Drug Administration (FDA) has approved REBLOZYL to treat patients with beta thalassemia requiring red blood cell transfusions.

As quoted in the press release:

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.¹ REBLOZYL is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy which works by regulating late-stage red blood cell maturation to help patients reduce their RBC transfusion burden.¹

“Today’s approval is an important milestone and underscores our continued commitment to patients with hematology disorders,” said Nadim Ahmed, President, Global Hematology and Oncology for Celgene. “There are very limited options for patients living with anemia due to beta thalassemia who are dependent on long term red blood cell transfusions. We are pleased to make REBLOZYL available as a new therapy for these patients to help address their anemia, a significant clinical complication of beta thalassemia.”²

“We’re thrilled that Acceleron’s first approved medicine is one with the potential to help patients with beta thalassemia, who have been in need of new treatments for this lifelong disease,” said Habib Dable, President and Chief Executive Officer of Acceleron. “We are enormously grateful to the patients, families and caregivers who participated in and supported our research. Their contributions have been essential in helping to ensure that REBLOZYL would emerge successfully from our longstanding collaboration with Celgene.”

Click here to read the full press release.