FDA orphan designation previously granted for the neonatal hypoxic-ischaemic encephalopathy (NHIE) treatment
GW Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted fast track designation for a proprietary intravenous form of cannabidiol (CBD) to treat neonatal hypoxic-ischaemic encephalopathy (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. There are currently no approved medicines in Europe or the US specifically indicated for NHIE or perinatal asphyxia.
‘GW believes that cannabinoids may have a potentially important role in the treatment of high need paediatric 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.
NHIE and perinatal asphyxia are forms of acute or sub-acute brain injury resulting from asphyxia caused during the birth process and subsequent deprivation of oxygen during birth (hypoxia). The incidence of these conditions is estimated to be approximately 12,000 to 24,000 cases per year in the United States and EU combined.
In financial news, the company has announced its results for the third quarter and 9 months ending 30 June 2015. Highlights include four Phase III epilepsy clinical trials under way, with the first being fully enrolled, and the establishment of US operations with the appointment of a new president and headquarters in Carlsbad, California.
‘GW has unprecedented momentum with four Phase III trials progressing for Epidiolex in paediatric epilepsy, as well as a full pipeline of other early and late stage clinical programmes across a range of indications,’ stated Justin Gover.
'We expect to carry this momentum through the remainder of 2015 as we approach pivotal Phase III data for Epidiolex and GW moves confidently forward with preparations for an expected NDA submission in 2016, as well as continuing to build a high quality US commercial infrastructure ahead of commercial launch,’ he added.