Global Blood Therapeutics' Oxbryta Scores European Approval For Sickle Cell Disease

The European Commission (EC) has approved Global Blood Therapeutics Inc's GBT Oxbryta (voxelotor) for hemolytic anemia due to sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). 

• Oxbryta, a once-daily, oral treatment, is the first medicine approved in Europe that directly inhibits sickle hemoglobin (HbS) polymerization, the molecular basis of sickling and destroying red blood cells in SCD.
• Related: FDA Expands Use Of Global Blood's Sickle Cell Treatment To Kids Aged 4-12 Years.
• The EC approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in December 2021 based on the Phase 3 HOPE study results demonstrating clinically meaningful and statistically significant improvements in hemoglobin (Hb) levels.
• In the HOPE Study, Oxbryta demonstrated a favorable safety profile with limited and transitory adverse reactions. 
• Price Action: GBT shares traded 2.40% lower at $31.26 on the last check Wednesday.