By Chris Wack
Bristol Myers Squibb said the U.S. Food and Drug Administration has accepted for priority review its supplemental Biologics License Application for Reblozyl luspatercept-aamt for the treatment of anemia in adults with non-transfusion dependent beta thalassemia.
The company said the FDA has set a Prescription Drug User Fee Act goal date of March 27, 2022.
Bristol Myers also said the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia. Reblozyl is being co-developed and co-commercialized with Merck & Co. Inc. following Merck's recent acquisition of Acceleron Pharma Inc.
These applications were based on safety and efficacy results from a Phase 2 study evaluating Reblozyl plus best supportive care in patients with NTD beta thalassemia.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires