Regulators on both sides of the Atlantic are now reviewing GW Pharmaceuticals’ cannabinoid Epidiolex as a potential treatment for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.
The submissions to the European Medicines Agency and the US Food and Drug Administration contain data from clinical trials showing that Epidiolex (cannabidiol) cut the monthly seizure rate in patients with these conditions, both rare and difficult to treat forms of childhood-onset epilepsy.
In one study, patients with LGS taking Epidiolex saw a median reduction in monthly seizures of up to 42 percent compared with a 17 percent drop for placebo.
In another involving children with Dravet syndrome, five percent became seizure free while taking the drug compared to none in the placebo arm, and patients also had a significantly greater median reduction in convulsive seizures (39 percent) compared to placebo (13 percent).
GW has received Orphan Designations from the EMA for Epidiolex for the treatment of LGS, Dravet syndrome as well as West syndrome and Tuberous Sclerosis Complex.
“GW is committed to making Epidiolex available to patients in Europe that struggle with the burden of living with LGS and Dravet syndrome, both very difficult to treat and devastating conditions. We continue to build a commercial infrastructure in Europe in anticipation of future approval and launch,” said Justin Gover, GW’s chief executive.
In the US, the drug has been awarded priority review status, which means the UK-headquartered firm should have an answer on whether it can be marketed in the country by June 27.
“We look forward to working with the FDA during the review process to support the case for approval of Epidiolex so as to provide a much needed new treatment option for patients that suffer from these highly treatment-resistant conditions of childhood-onset epilepsy,” Gover noted.