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Home 🌿 Marijuana Business News 🌿 GW Pharma's cannabidiol Fast Track'd for NHIE 🌿

GW Pharma's cannabidiol Fast Track'd for NHIE

Submitted by Marijuana News on Thu, 08/06/2015 - 12:37
  • The FDA designates GW Pharmaceuticals' (NASDAQ:GWPH) intravenous cannabidiol for Fast Track review for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). The European Medicines Agency also designates it an Orphan Drug for NHIE, a status granted earlier by the FDA.
  • NHIE and perinatal asphyxia are forms of acute or sub-acute brain injury due to the lack of oxygen during birth. There are as many as 24K cases per year in the U.S. and Europe. The mortality rate is ~35% while ~30% experience permanent disability. The current standard of care for perinatal asphyxia is to induce whole-body hypothermia (lower the body's temperature). The treatment is only available in specialized neonatal ICUs and must be started within six hours of birth.
  • Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the NDA. Among the benefits of Orphan Drug status
    • ...
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