Food and Drugs Administration (FDA)
OXBRYTA approved by United states Food and Drug Administration. FDA approved oxbryta ( voxelotor), an oral therapy taken daily and the first approved treatment that directly prevent red blood cells from sickling ( the root cause of SCD)
Every person with sickle cell disease (SCD) experiences hemoglobin polymerization ( sickling), and suffers from varying severity of anemia and hemolysis; the rapid breakdown of red blood cells.
The accelerated approval of oxbryta was based on the data from phase 3 HOPE study of 274 patients which were 12years of age and older with SCD, showed that after 24 weeks of treatment, 51.1% of patients receiving oxbryta achieved a greater than 1g/dL increase in hemoglobin compared with 6.5% receiving placebo.
source : www.sc101.org/igbio