Published on: 25/09/19
The European Commission has approved the use of Epidyolex, a cannabis-based medicine, in the UK and Europe to treat seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. Both syndromes affect children and can cause multiple seizures daily. The oral medication can be used by children two years and up.
As reported by the BBC, the medication, already on the US market, should be available soon in the UK and Europe.
The National Institute for Clinical Excellence (NICE) decided not to approve prescription of Epidyolex last month because of the lack of evidence showing long-term effectiveness. However, NICE and GW Pharmaceuticals, the manufacturer of Epidyolex, said last month that they are continuing to work together.
Epidyolex’s approval is considered a milestone, being the first EMA-approved CBD [cannabidiol] medicine to treat two severe forms of childhood-onset epilepsy.
Elinor Ben-Menachem, professor of neurology and epilepsy at the University of Gothenburg’s Sahlgren Academy, said in the Guardian: “The EMA approval of Epidyolex will bring hope to patients and families, with the potential to better control seizures and improve quality of life.”
Epilepsy Society welcomed the approval of Epidyolex for the UK and European markets. The charity’s medical director, Professor Ley Sander, said: "These are both severe childhood epilepsies which can be very debilitating. This new drug will bring hope for some families and European approval feels like a positive step.”
Epilepsy Action on Twitter said: “Very welcome announcement from @EMA_News who have approved Epidyolex for seizures associated with Dravet and lennox-Gasatut syndromes in the EU. This does not immediately change the UK situation but is a positive step forwards for many people affected.”
The Guardian reported that Epidyolex significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome, when combined with other anti-epileptic therapies.
Read more about medicinal cannabis use for epilepsy here.
