Benzinga | Sep 7, 2021 09:33AM EDT

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

* 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.