Oxbryta would be the first treatment targeting the root cause of SCD, hemolytic anemia, to be approved in the EU.
Global Blood Therapeutics , Inc. (GBT) (NASDAQ: GBT) today announced that the European Medicines Agency (EMA) has completed the validation of GBT’s Marketing Authorization Application (MAA) for Oxbryta® (voxelotor) tablets and started its standard review process. GBT is seeking full marketing approval from the EMA for Oxbryta to treat hemolytic anemia in patients with sickle cell disease (SCD) who are 12 years of age and older.