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BMS Forgoes Thalassemia Label Expansion Revenues For Rebozyl

Withdraws Reblozyl sBLA

 
• By Ayisha Sharma

The firm was unable to respond to the US FDA’s questions on Reblozyl’s risk-benefit profile in an expanded beta-thalassemia setting and will now focus label expansion efforts elsewhere.    

BMS Is Doing A U-Turn On Its Expansion Plans For Reblozyl • Source: Shutterstock

Bristol Myers Squibb Company’s withdrawal of its supplemental biologics license application for Reblozyl (luspatercept) in anemia in non-transfusion dependent beta-thalassemia may have cost it more than $500m in annual revenues.

The firm revealed on 3 June it could not appropriately address the US Food and Drug Administration’s questions concerning the Reblozyl’s risk-benefit profile based on data from the Phase II BEYOND trial and confirmed it would no longer pursue this indication in the US

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