European regulators approve cannabis drug for severe childhood epilepsy
European regulators have, for the first time, approved a drug containing cannabis for rare, but severe, forms of childhood epilepsy.
The drug Epidyolex is now available for use in the UK and other European countries, and is an oral solution of cannabidiol (CBD), which comes from the cannabis plant.
However, the National Institute for Health and Care Excellence (Nice) has not approved the medicine for the NHS in draft guidance, due to concerns over its long-term effectiveness.
The drug does not contain any tetrahydrocannabinol (THC), a component of cannabis which some parents of ill children say is the thing that helps the most.
Epidyolex is a treatment for children with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, from the age of two.
Ley Sander (pictured), medical director at Epilepsy Society and professor of neurology at University College London, said: “There is evidence to show that pharmaceutical grade CBD, under the trade name Epidyolex, is effective in reducing seizures in some children with Dravet syndrome and Lennox-Gastaut.
“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.
“Medicinal cannabis, however, still remains a medical minefield and there are many hurdles ahead.
“CBD was not recommended by Nice for prescription on the NHS.
“It is important that the pharmaceutical industry continues to work with the medical advisory body to ensure that drugs are cost-effective and that its long-term effects are clear.
“It is important that the medical profession, regulatory and advisory bodies remain level-headed in ensuring that the medications prescribed to people in the UK are rigorously tested and economically viable.
“If a drug holds promise in treating a condition, it is important that it is available for all those who require it and that it does not become another victim of a postcode lottery.”
GW Pharmaceuticals, which makes the drug, said the next step will be to secure a recommendation from Nice.
Justin Gover, chief executive of GW, said: “”The approval of Epidyolex marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines.
“We believe patients and physicians deserve access to rigorously-tested and evaluated cannabis-based medicines, manufactured to the highest standards and approved by medicines regulators, and we are delighted to be the first to offer this solution to the epilepsy community.”
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