The agency gave accelerated approval to GBT's Oxbryta (voxelotor) for sickle cell disease in patients aged 12 and older. The drug works by inhibiting sickle hemoglobin polymerization.
The agency granted the application for accelerated approval priority review, but is not requiring an advisory committee meeting. A confirmatory trial measuring the drug's ability to reduce stroke risk is planned for the fourth quarter.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The company presented updated data for the drug, voxelotor, at the European Hematology Association conference in Amsterdam Friday.