EMA accepts GBT's application for Oxbryta approval

27 January 2021

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US biopharma company Global Blood Therapeutics (Nasdaq: GBT) today announced that the European Medicines Agency has completed the validation of GBT’s Marketing Authorization Application (MAA) for Oxbryta (voxelotor) tablets and started its standard review process.

GBT, whose shares edged up 1.3% to $48.11 in early trading, 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.

A first-in-class oral, once-daily therapy, Oxbryta directly inhibits hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD. The sickling process causes hemolytic anemia (low hemoglobin due to red blood cell destruction) and blockages in capillaries and small blood vessels, which impede the flow of blood and oxygen throughout the body.

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