The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of cannabidiol oral solution (Epidyolex, GW Pharma) as add-on therapy for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in conjunction with clobazam (multiple brands) for patients as young as 2 years.
The US FDA approved GW’s cannabidiol oral solution last year under the trade name Epidiolex, as reported by Medscape Medical News.
The CHMP’s positive opinion is based on results from four randomized, controlled phase 3 trials that included 714 patients with either LGS or Dravet syndrome. Results showed that add-on therapy with the cannabidiol product was more effective than placebo in reducing seizure frequency.
“This is a significant milestone for patients with LGS and Dravet syndrome as there remains a severe unmet medical need for these rare, lifelong forms of epilepsy,” Martin Brodie, MD, president of the International Bureau for Epilepsy, said in a news release from the drugmaker.