GW Pharmaceuticals Receives U.S. FDA Fast Track
GW Pharmaceuticals plc has received an 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 (NHIE), and a orphan designation for the same product from The European Medicines Agency (EMA) to treat perinetal asphyxia.
NHIE and perinatal asphyxia are forms of acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth. The incidence of these conditions is estimated to be approximately 12,000 to 24,000 combined cases per year in the United States and European United. Of these cases, 35% are expected to die in early life and 30% may suffer from permanent disability. The current standard of care for perinatal asphyxia patients is to induce whole-body hypothermia, which is only available in specialized neonatal intensive care units, and still offers a significant rate of morbidity and mortality. Amongst the patients who survive 28% suffer from major neurodevelopment issues and 26% develop Cerebral Palsy.
“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,” stated Justin Gover, GW’s Chief Executive Officer in a company issued press release. “GW is now working towards the launch of a clinical development program in this important medical condition towards the end of this year.”
FDA’s Fast Track program facilitates the development and review of drugs intended to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval to get important new drugs to the patient earlier.
The EMA orphan designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union must not be more than 5 in 10,000) and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life-threatening or a chronically debilitating rare disease. The incentives can include reduced fees and protection from competition once the medicine is placed on the market.
The Company has already received an 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.