Positive pivotal Ph III BELIEVE trial of Reblozyl in adult patients with beta thalassemia

The New England Journal of Medicine (NEJM) has published results from BELIEVE, the pivotal Phase III study evaluating the safety and efficacy of Reblozyl (luspatercept-aamt) for the treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions, says Bristol-Myers Squibb (NYSE: BMS), which is the marketer of the drug, and saw its share rise more than 5% to $51.89 by early afternoon trading today.

“These results published in the New England Journal of Medicine demonstrate the clinical benefit of Reblozyl, the first approved treatment for anemia in beta thalassemia in the US,” said Dr Diane McDowell, vice president, hematology global medical affairs, Bristol Myers Squibb. “Patients with beta thalassemia experience chronic anemia, often requiring life-long treatment with red blood cell transfusions, which are associated with multiple medical complications.  The ability of Reblozyl to reduce the frequency and burden of regular red blood cell transfusions is clinically meaningful for these patients.”

The US Food and Drug Administration granted approval to Reblozyl, which is being developed by now a B-MS company Celgene and Acceleron Pharma (Nasdaq: XLRN), for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions in November last year.