The European Union has approved its first medical cannabis product in order to help doctors across the continent treat children with severe epilepsy.
Epidyolex is an oral CBD solution produced by British company GW Pharmaceuticals (Nasdaq: GWPH). It is used to treat patients who suffer from Lennox‑Gastaut syndrome and Dravet syndrome, two rare but severe forms of childhood epilepsy.
It is registered as Epidiolex in the U.S. and last year it became the first cannabis-based medicine to secure FDA approval to treat Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older. Doctors across the USA and Europe can now prescribe it to patients.
“The approval of Epidyolex marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” said Justin Gover, chief executive at GW Pharma.
Isabella Brambilla, chairman at the Dravet Syndrome European Federation, called the news “an important milestone”.
Ley Sander, medical director at the Epilepsy Society and Professor of Neurology at University College London, was among the experts to welcome the news, along with Professor Elinor Ben-Menachem of the University of Goteborg, Sahlgren Academy and Hospital in Sweden.
The approval of Epidyolex is based on results from four controlled trials on more than 700 patients. Many children suffering from Lennox-Gastaut or Dravet syndromes suffer multiple seizures per day and they are at risk of injury from falls. Both forms of epilepsy are hard to treat, and CBD has helped many sufferers enormously.
Many countries across Europe have legalized medicinal marijuana, including Germany, Italy, and the Netherlands. However, this is the first time the EU has given its stamp of approval.
It could help with legalization efforts in countries like France, and it may pile further pressure on the NHS in Britain to allow doctors to prescribe Epidyolex for patients.
Last month, the UK’s National Institute for Health and Care Excellence made an initial decision not to recommend prescribing Epidyolex due to lack of evidence of long-term effectiveness.