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In a landmark ruling, the EU has issued consent for the use of a medical cannabis product for the treatment of severe epilepsy in children as young as two.
The medical cannabis product, EPIDYOLEX® is an oral solution of cannabidiol and is effective at treating epilepsy – the medicine can be prescribed by doctors to treat rare, but severe, forms of childhood epilepsy such as Lennox-Gastaut syndrome or Dravet syndrome – difficult-to-treat conditions that can cause multiple seizures a day.
“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.
“This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community. 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,” said Justin Gover, GW’s Chief Executive Officer.
Ley Sander, Medical Director at the Epilepsy Society and Professor of Neurology at University College London, said: “This new drug will bring hope for some families and EU 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.”
Despite approval for use, the UK’s arm for healthcare, the NHS does not recommend it.
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. However, final guidance is expected later this year, with the EU decision likely to sway opinions.
What is EPIDYOLEX® ?
The drug does not contain any of the psycho-active component of cannabis, a compound called tetrahydrocannabinol (THC).
Some parents, who have travelled to the Netherlands to buy cannabis medicines, feel the treatment will not help many children because it does not contain THC, which they argue has helped their children.
The use of ones containing THC was legalised across the UK in November 2018 – a process which was spearheaded by Hannah Deacon, a medical cannabis campaigner who is scheduled to speak at the upcoming Medical Cannabiz World Summit in November. These treatments can be prescribed only by specialist doctors in a limited number of circumstances where other medicines have failed.
Few of these unlicensed prescriptions have been made on the NHS, a concern which will be addressed in the upcoming Medical Cannabiz Summit conferences by a number of speakers, including Prof. Mike Barnes, Chair for The Medical Cannabis Clinicians Society.
The EC decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein.
The Medical Cannabiz World Summit will take place from the 4th to 5th November at the Intercontinental, St Julian’s, Malta, to be followed by the inaugural launch of the Medical Cannabiz World Asia Summit which will be held in Bangkok on the 22nd and 23rd of June 2020 at the Centara Grand Hotel.
Watch an exclusive clip with Hannah Deacon below or read her interview in the latest issue of Cannabiz Magazine: