GW Pharmaceuticals granted Fast Track designation by FDA and orphan designation by EMA

UK biopharma company GW Pharmaceuticals (AIM: GWP) has been granted Fast Track designation by the US Food and Drug Administration for its proprietary intravenous form of cannabidiol to treat neonatal hypoxic-ischemic encephalopathy (NHIE).

The European Medicines Agency has granted orphan designation for the same product for perinatal asphyxia, an alternative term for the same indication. There are currently no specifically indicated medicines for this condition in the USA or Europe.

Justin Gover, chief executive of GW, said: "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. 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."