Bris­tol My­ers pulls plug on Re­blozyl pro­gram for rare blood dis­or­der, months af­ter missed PDU­FA date

Bris­tol My­ers Squibb laid out some big plans over the last cou­ple of years for its Cel­gene-ac­quired ane­mia drug Re­blozyl, fore­cast­ing a $4 bil­lion-plus peak sales es­ti­mate on the back of sev­er­al po­ten­tial la­bel ex­pan­sions.

But it looks like one of those ad­di­tions just isn’t in the cards, as reg­u­la­tors call in­to ques­tion the drug’s risk-ben­e­fit pro­file in a rare blood dis­or­der.

BMS pulled the plug on its Re­blozyl pro­gram for ane­mia in adults with non-trans­fu­sion de­pen­dent (NTD) be­ta tha­lassemia on Mon­day, with­draw­ing its sup­ple­men­tal bi­o­log­ics li­cense ap­pli­ca­tion (sBLA) be­cause it “could not ap­pro­pri­ate­ly ad­dress the U.S. Food and Drug Ad­min­is­tra­tion’s ques­tions about the ben­e­fit-risk pro­file of Re­blozyl in this pa­tient pop­u­la­tion based on the cur­rent dataset.”

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