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Global Blood's Sickle Cell Medicine Under FDA Review For Expanded Use

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  • The FDA has accepted Global Blood Therapeutics Inc's (GBT) (NASDAQ: GBT) supplemental application seeking accelerated approval for Oxbryta (voxelotor) for sickle cell disease (SCD) in children ages 4 to 11 years.

  • The agency has also accepted a marketing application for a new age-appropriate dispersible tablet dosage form of Oxbryta suitable for pediatric patients.

  • Oxbryta is currently approved by the FDA in a tablet dosage form to treat SCD in patients age 12 years and older.

  • The FDA granted Priority Review for both the applications, providing a six-month review, and assigned a Prescription Drug User Fee Act (PDUFA) target action date for both applications of December 25.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: GBT shares are up 1.97% at $30.76 during the market session on the last check Tuesday.

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