Datapoint: FDA Delays Decision on Reblozyl Label Expansion

The FDA has delayed its review of Bristol Myers Squibb and Merck’s Reblozyl for anemia from non-transfusion-dependent beta thalassemia until late June, according to a news release from BMS. The agency said it needs the extra time as a “written response to an information request was determined by the FDA to constitute a major amendment,” though BMS did not reveal what the information request entails. For the treatment of transfusion-dependent anemia-associated beta thalassemia, Reblozyl holds covered or better status for 58% of all insured lives under the pharmacy benefit. Under the medical benefit, 83% of all insured lives have covered or better access to Reblozyl.

SOURCE: MMIT Analytics, as of 3/30/22

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