Bristol Myers gets regulatory approval for anemia drug Reblozyl, secures FDA label expansion

Bris­tol My­ers Squibb has scored an­oth­er win for its ane­mia drug Re­blozyl, re­veal­ing Mon­day evening the FDA grant­ed the drug its third in­di­ca­tion.

The FDA ap­proved the drug as a front­line treat­ment for adult ane­mia pa­tients with low­er-risk myelodys­plas­tic syn­dromes (MDS) who may re­quire red blood cell trans­fu­sions, and who al­so had not used ery­thro­poiesis-stim­u­lat­ing agents, or ESAs.

The agency ac­cept­ed an sN­DA for the drug back in May, grant­i­ng it pri­or­i­ty re­view.

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