GBT Receives MHRA’s Marketing Authorization for Oxbryta (voxelotor) to Treat Hemolytic Anemia in Patients with Sickle Cell Disease Aged ≥12 Years in Great Britain
Shots:
- The MHRA has granted marketing authorization to Oxbryta (voxelotor) as monothx. or in combination with hydroxycarbamide for hemolytic anemia due to SCD in adult and pediatric patients aged ≥12yrs.
- The marketing authorization was based on the P-III (HOPE) study of Oxbryta vs PBO in 274 patients aged ≥12yrs. with SCD which showed that 51.1% vs 6.5% of patients achieved a ≥1 g/dL increase in Hb with significant improvements in markers of hemolysis in indirect bilirubin and reticulocyte percentage @24wks.
- The marketing authorization will be valid in all EU member states & additional member states of the EEA, incl. Iceland, Liechtenstein, and Norway
Ref: GlobalNewswire | Image: GBT
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