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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