Posted by Michael Wonder on 29 Jul 2019
GW Pharmaceuticals receives positive CHMP opinion for Epidyolex (cannabidiol oral solution) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy
26 July 2019 - If approved cannabidiol oral solution will be the first plant-derived cannabis-based medicine to be approved in Europe for the treatment of any form of epilepsy.
GW Pharmaceuticals today announced that the EMA CHMP has adopted a positive opinion recommending marketing authorisation of Epidyolex (cannabidiol oral solution) 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 CHMP’s positive opinion 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 forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers.
