GW’s extensive research into the pharmacology of cannabinoids continues to yield highly promising data and new intellectual property across a range of therapeutic areas. GW continues to invest in research to accelerate further growth and value creation through the development of medicines that address serious unmet medical needs.
GW’s lead product candidate is a pharmaceutical formulation of purified CBD for severe early-onset, drug-resistant epilepsy syndromes. This product is the result of extensive pre-clinical research of CBD in epilepsy which dates back to 2007. In 2013, GW commenced an orphan clinical program in pediatric epilepsy with initial focus on two rare and particularly difficult to treat forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome (LGS), both of which have been granted orphan drug designation by the U.S. FDA.
GW submitted a New Drug Application with the FDA , which was approved by the FDA on June 25th, 2018 for the treatment of seizures associated with LGS or Dravet syndrome. Epidiolex was launched in the U.S. and available by prescription on November 1st, 2018. GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected decision date in early 2019. To date, GW has received Orphan Drug Designation from the FDA for Dravet syndrome, LGS, TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for the treatment of LGS, Dravet syndrome, West syndrome and TSC. GW is currently evaluating additional clinical development programs in other orphan seizure disorders.
- GW’s current Phase 3 pivotal trials program includes two Phase 3 trials in Dravet syndrome, two in LGS and one in TSC (see GW press releases: 14 March 2016 & 27 June 2016, 26 September 2016, 16 May 2018).
- To learn more about these clinical trials please see the ClinicalTrials.gov website here.