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GW Pharma Receives FDA Fast Track and EMA Orphan Designations

Relates to an intravenous cannabidiol to treat neonatal hypoxic-ischemic encephalopathy (NHIE)

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, said that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for a proprietary intravenous form of cannabidiol (CBD) to treat Neonatal Hypoxic-Ischemic Encephalopathy, or NHIE. In addition, the European Medicines Agency (EMA) has granted orphan designation for the same product to treat perinatal asphyxia, an alternate term that describes the same condition as NHIE, for which GW has already received Orphan Drug Designation from the FDA. There are currently no approved medicines in Europe or the U.S. specifically indicated for NHIE or perinatal asphyxia.

“GW believes that cannabinoids may have a potentially important role in the treatment of high need pediatric neurologic conditions. As a result, we have developed a proprietary intravenous CBD formulation specifically for use in this most vulnerable of patient populations, newborn infants with NHIE,” said Justin Gover, GW’s chief executive officer. “As there are no current treatment options beyond induced hypothermia for the affected newborns, there exists a dramatic need to develop new and effective therapies aimed at preventing acute brain damage and enhancing long-term brain repair. GW is now working towards the launch of a clinical development program in this important medical condition towards the end of this year.”

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