Posted by Michael Wonder on 24 Sep 2019
GW Pharmaceuticals receives European Commission approval for Epidyolex (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy
23 September 2019 - Cannabidiol oral solution is the first plant-derived cannabis-based medicine to be approved by the EMA.
GW Pharmaceuticals today announces that the European Commission has approved the marketing authorisation for Epidyolex for use as adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older. The approval paves the way for the launch of the medicine across Europe.
The approval of cannabidiol oral solution is based on results from four randomised, controlled Phase 3 trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers.
