FDA grants priority review to Reblozyl for beta-thalassemia subset
Click Here to Manage Email Alerts
The FDA granted priority review to luspatercept-aamt for treatment of anemia among adults with non-transfusion-dependent beta-thalassemia.
Luspatercept-aamt (Reblozyl, Bristol Myers Squibb) is an erythroid maturation agent.
The agent is approved in the United States for treatment of anemia among adults with beta-thalassemia who require regular red blood cell transfusions. It also is approved for treatment of certain patients with anemia associated with lower-risk myelodysplastic syndrome.
A supplemental new drug application for the non-transfusion-dependent beta-thalassemia indication is based on results of the randomized phase 2 BEYOND study, which assessed the addition of luspatercept-aamt to best supportive care.
Updated results of the BEYOND study will be presented at this year’s ASH Annual Meeting and Exposition, which will be held Dec. 11-14.
The FDA is expected to make a decision on approval of this indication by March 27.
“Patients with non-transfusion-dependent beta-thalassemia may not require lifelong blood transfusions for survival, but their need for effective treatment options is significant as they face a range of clinical complications due to chronic anemia and iron overload,” Noah Berkowitz, MD, PhD, senior vice president of hematology development at Bristol Myers Squibb, said in a company-issued press release.
Read more about
Click Here to Manage Email Alerts