Oxbryta™ (Voxelotor) is granted priority review for the treatment of SCD in children ages 4 to 11

The U.S. Food and Drug Administration (FDA)  has accepted Global Blood Therapeutics’ (GBT’s) supplemental New Drug Application (sNDA) seeking accelerated approval for Oxbryta® (voxelotor) for the treatment of sickle cell disease (SCD) in children ages 4 to 11 years and its New Drug Application (NDA) seeking approval for a new age-appropriate dispersible tablet dosage form of Oxbryta suitable for pediatric patients (i.e., 300 mg grape flavoring tablets). Oxbryta is currently approved by the FDA in a tablet dosage form to treat SCD in patients age 12 years and older. Oxbryta is a first-in-class therapy that directly targets hemoglobin polymerization, the root cause of red blood cell sickling in SCD. For more information, read GBT press release here