Shots:

• The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization for Oxbryta to treat hemolytic anemia due to SCD in patients aged ≥12yrs. as monothx or in combination with hydroxycarbamide
• The CHMP opinion is based on the P-III (HOPE) study of Oxbryta vs PBO in 274 patients aged ≥12yrs. with SCD which showed that patients achieved a 1 g/dL increase in Hb (51.1% vs 6.5%) @24wks., improvements in markers of hemolysis in indirect bilirubin & reticulocyte percentage & a favorable safety profile
• If approved by the EC, Oxbryta will receive marketing authorization in all EU member states, Iceland, Liechtenstein & Norway with an expected EC’s decision in Q1’22

Ref: Globe Newswire | Image: GBT