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Global Blood's Oxbryta (Voxelotor) Receives the US FDA's Accelerated Approval for Treatment of Sickle Cell Disease

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Global Blood's Oxbryta (Voxelotor) Receives the US FDA's Accelerated Approval for Treatment of Sickle Cell Disease

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  • The approval is based on P-III HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) study assessing Oxbryta vs PBO in 274 patients of 12 years and older with SCD
  • The study resulted in achieving greater than 1g/dL increase in hemoglobin (51.1% vs 6.5%)- Published in NEJM Jun’2019  
  • Oxbryta (bid) is an orally administered drug the first approved treatment that directly inhibits sickle hemoglobin polymerization for SCD and has is reviewed under Priority Review received BT designation FT- ODD and Rare Pediatric Disease designations for the treatment of patients with SCD

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Twitter


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