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

The FDA has accepted Global Blood Therapeutics Inc's (GBT) 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.