Bristol Myers Squibb: FDA Extends PDUFA Goal Date For Reblozy By Three Months For Full Review

(RTTNews) - Bristol Myers Squibb (BMY) announced the FDA has extended the review of the supplemental biologics license application for Reblozyl for the treatment of anemia in adults with non-transfusion-dependent beta thalassemia to June 27, 2022. The company said a written response to an information request was determined by the FDA to constitute a major amendment. As a result, the FDA has extended the PDUFA goal date by three months to provide time for a full review of the submission.

Reblozyl is being developed and commercialized by Bristol Myers Squibb through a global collaboration with Merck & Co., Inc. There is an application under review by the European Medicines Agency.