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# Review Extension Bristol-Myers sBLA for Reblozyl
- URL: https://www.fdaweb.com/review-extension-bristol-myers-sbla-for-reblozyl/
- Published: 2022-03-25T12:00:00.000Z
- Updated: 2026-09-14T17:38:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151453

FDA has extended by three months its review of a Bristol-Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion-dependent beta thalassemia. The submission was based on safety and efficacy results from the pivotal Phase 2 BEYOND study.

The company says it responded to a written request for information that FDA determined to be a major amendment and the extra review period will give the agency time to review the information in the response. The agency has set a new user fee review action target date of 6/27.