GBT filings accepted for priority review
Global Blood Therapeutics (Nasdaq: GBT) has announced that the US Food and Drug Administration (FDA) has accepted for filing and review two submissions relating to Oxbryta (voxelotor).
One is a supplemental New Drug Application (sNDA) seeking approval of Oxbryta for the treatment of sickle cell disease (SCD) in children aged four to 11 years, and the other is a New Drug Application (NDA) for a new age-appropriate dispersible tablet dosage form of Oxbryta suitable for pediatric patients.
"An important step toward achieving GBT’s goal of bringing Oxbryta to all eligible patients suffering from this devastating disease"Oxbryta, a first-in-class therapy that directly targets hemoglobin polymerization, the root cause of red blood cell sickling in SCD, is currently approved by the FDA in a tablet dosage form to treat SCD in patients age 12 years and older.
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