MHRA Authorizes Global Blood Therapeutics’ Oxbryta for SCD-Related Hemolytic Anemia

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Global Blood Therapeutics’ oral drug Oxbryta (voxelotor) for treatment of hemolytic anemia due to sickle cell disease (SCD).

The authorization is specifically for adult and pediatric patients 12 years of age and older as a monotherapy or in combination with hydroxycarbamide (hydroxyurea).

The drug demonstrated significant improvements in hemoglobin levels and reduced hemolysis markers in clinical studies.

In 2021, the MHRA granted the drug a Promising Innovative Medicine designation and allowed early access that enabled healthcare professionals to treat some patients with the drug prior to the market authorization.

The EU granted marketing authorization for Oxbryta for the same indication in February.