Global Blood Therapeutics (NASDAQ:GBT) +4.8% after-hours, saying it plans to ask the Food and Drug Administration to allow expanded use of its Oxbryta sickle cell treatment in children aged 4-11 years, expanding on an earlier approval for patients 12 and over.
The company says it recently met with the FDA and plans to submit a formal application for expanded approval next year.
“We’ve got a significant amount of data
that really reinforces that the drug has a very similar profile for
both safety and efficacy in this age group,” CEO Ted Love tells Reuters.
Global Blood’s Oxbryta (voxelotor) is the only
therapy that directly inhibits hemoglobin polymerization, the root cause
of the sickling and destruction of red blood cells in sickle cell
disease.
https://seekingalpha.com/news/3581359-global-blood-therapeutics-to-seek-expanded-labeling-for-sickle-cell-drug
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