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

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

Shots:

  • 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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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