FDA Expands Use Of Global Blood' Sickle Cell Treatment To Kids Aged 4-12 Years

The FDA has granted accelerated approval to Global Blood Therapeutics Inc's GBT supplemental application seeking approval for Oxbryta (voxelotor) tablets for sickle cell disease (SCD) in children ages 4 to less than 12 years.

• This approval expands the previously approved use of Oxbryta to treat SCD in patients ages 12 years and older in the U.S.
• Related content: Benzinga's Full FDA Calendar.
• The FDA also approved GBT's separate marketing application (NDA) for Oxbryta tablets for oral suspension, a new dispersible, once-daily tablet dosage form suitable for patients ages 4 to less than 12 years and older patients who have difficulty swallowing whole tablets. 
• The company says that Oxbryta is the first and only approved medicine that directly targets sickle hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD.
• Price Action: GBT shares are closed higher by 10.49% at $30.55 on Friday.