GBT’s Oxbryta (voxelotor) Receives EC’s Approval for the Treatment of Hemolytic Anemia in Patients with Sickle Cell Disease
Shots:
- The EC has granted marketing authorization for Oxbryta in adult & pediatric patients aged ≥12yrs. as monothx. or in combination with hydroxycarbamide to treat hemolytic anemia due to SCD
- The approval was based on the results from the P-III (HOPE) study which showed an improvement in Hb levels. The therapy showed a favorable safety profile with limited and transitory adverse reactions
- Oxbryta has received marketing authorization in the EU member states, Iceland, Liechtenstein & Norway. The therapy also received PRIME designation from the EMA while the company has submitted an application to the MHRA for marketing authorization in Great Britain using the EC decision reliance procedure
to Ref: Globe Newswire | Image: GBT
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