The US Food and Drug Administration (FDA) has accepted a recently submitted new drug application (NDA) for cannabidiol (CBD) Epidiolex, which was filed by GW Pharmaceuticals.
Epidiolex is an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, which are rare conditions developed on childhood-onset epilepsy.
The NDA’s review is expected to be completed in June this year and the FDA is also planning an advisory committee meeting to discuss the application.
GW Pharmaceuticals CEO Justin Gover said: “We are pleased with the FDA’s acceptance of our NDA filing with Priority Review, an action that underscores the unmet need in the LGS and Dravet syndrome populations.
“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.”
GW has already received Orphan Drug Designation from the FDA and the European Medicines Agency (EMA) for Epidiolex to treat LGS and Dravet syndrome, as well as other medical conditions.
The company expects to launch the drug in the US this year following approval.
LGS is caused by multiple conditions including brain malformations, severe head injuries, central nervous system (CNS) infections and genetic neuro-degenerative or metabolic conditions.
A highly treatment-resistant epileptic encephalopathy, Dravet syndrome typically affects infants in the first year of life. Children with LGS exhibit some degree of intellectual impairment and developmental delays.
Dravet syndrome patients often develop seizures over time, including tonic-clonic, myoclonic, atypical absences and life-threatening status epilepticus.