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expert reaction to EMA granting a positive opinion for Epidyolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two forms of epilepsy

At a meeting from July 22nd-25th, the European Medicines Agency (EMA) granted positive approval for the use of Epidyolex (cannabidiol) in the treatment of two forms of epilepsy.

 

Prof David Nutt, The Edmond J Safra Chair and Head of the Centre for Neuropsychopharmacology, Imperial College London, said:

“This is not a surprising or important step.  Many European countries have had approval for several decades for Sativex, which is also a cannabis plant extract, and Epidyolex itself has been licensed in the USA since last year.  Yes this is the first Europe-wide decision, but that’s not important to my mind – the much more interesting question is whether NICE will approve it as it’s very expensive.  Cannabidiol has been proven to treat these seizures for a decade – there is really nothing important in this decision, it is simply a rational regulatory response to decent data set.  Cannabis has been a medicine for over two millennia!”

 

Mr Ian Hamilton, Lecturer in Mental Health, University of York, said:

“The approval of Epidyolex might give hope to some people in the United Kingdom, however there are significant problems for people trying to secure prescriptions of cannabis based products in the UK, with only a handful of NHS prescriptions issued so far, many people are turning to private clinics and doctors who seem more willing and able to facilitate access to these products.  This clearly isn’t fair as not everyone will have the financial means to meet the costs of private health care.  So the main problem we now have is access to cannabis based products rather than availability and efficacy of these products.”

 

* https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2019

 

Declared interests

Mr Ian Hamilton: “No conflict of interest to declare.”

None others received.

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