Bristol-Myers: FDA Extends Review of Application for Expanded Reblozyl Use

 Bristol-Myers Squibb Co. on Friday said the U.S. Food and Drug Administration has extended by three months the review of its application seeking expanded approval of Reblozyl for the treatment of anemia in adults with non-transfusion-dependent beta thalassemia.

The New York biopharmaceutical company said the FDA determined that a written response to an information request by the agency constitutes a major amendment to the application and set a new target action date of June 27 to provide time for a full review of the submission.

The FDA had previously granted priority review to the application, with a target action date of March 27.

Bristol-Myers is developing and commercializing the anemia drug under a 2011 collaboration with Acceleron Pharma Inc., which Kenilworth, N.J., drugmaker Merck & Co. acquired last year for $11.5 billion.

Reblozyl is currently approved in the U.S. and European Union to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes failing an erythropoietin-stimulating agent and requiring red-blood-cell transfusions.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-FDA-Extends-Review-of-Application-for-Expanded-Reblozyl-Use-39862704/