The European Commission (EC) has approved Global Blood Therapeutics Inc's (NASDAQ: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.
