FDA Approval Sought for Oxbryta for Children Ages 4–11

FDA Approval Sought for Oxbryta for Children Ages 4–11

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FDA Approval Sought for Oxbryta for Children Ages 4–11

Children with sickle cell disease (SCD) as young as age 4 could be prescribed Oxbryta (voxelotor) if the U.S. Food and Drug Administration approves a supplemental new drug application (sNDA) submitted by the therapy’s developers. Global Blood Therapeutics (GBT) is asking the FDA to expand the use of Oxbryta — the first approved therapy targeting the underlying cause of SCD — to children ages 4 and older who have the inherited blood disease. The therapy’s current…

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