Epidyolex approved for use in over 30 European Countries

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Patients in over 30 European countries could soon be able to get access to GW Pharmaceuticals Epidyolex cannabis medicine after it was approved by the European Commission.

Since its launch in the U.S last year GW’s sales have rocketed with Epidiolex (as it is known in America) boosting its revenues by over $30m in its first quarter, with more than 7,600 patients accessing the drug.

Now the European Medicines Agency has approved marketing authorisation in the 28 member states of the European Union, for its use for two conditions associated with childhood epilepsy; Lennox‑Gastaut syndrome and Dravet syndrome.

The medicine – a strawberry-flavoured oral CBD with the anti-seizure drug clobazam – can now be launched across Europe. Up to 50,000 children and young adults in Europe have one of the two syndromes, reports The Guardian newspaper.

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GW was formed in the 1990s and and created one of the first medical cannabis medicines with Sativex – a one to one combination of CBD and THC – used to treat muscle spasms caused by MS and other conditions. In its market statement on the EC approval GW said it had stemmed from the results of four randomised, controlled Phase 3 trials, incorporating data from more than 714 patients.

In GW’s press release Isabella Brambilla, Chairman, Dravet Syndrome European Federation said: “The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex and life-long forms of epilepsy.”

In an earlier market statement GW said it was looking at five European markets to initially launch Epidyolex: France, Germany and the U.K. with the other two unnamed countries to follow. Justin Gover, GW’s Chief Executive Officer said the approval is the realisation of ‘many years of dedication and collaboration between GW, physicians and the epilepsy community’. 

He added: “We are delighted to be the first to offer this solution to the epilepsy community.”

The E.C. decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein. However, despite this good news GW has still to convince the U.K. medical authorities to approve both Epidyolex and Sativex.

In the last few weeks, the U.K. deemed both to be too costly at around £30,000 a year. GW’s chief operating officer, Chris Tovey, said the company was in discussions with the UK’s National Institute for Health and Care Excellence (NICE) about making the drug available on the NHS. 

He said: “The feedback [in the US] has been incredibly positive.” He said it is ‘very optimistic’ that NICE would agree to fund Epidiolex. We are hoping for a relatively rapid decision from NICE and we are hoping to make it available for U.K. patients in the next couple of months,” he said in a press release.

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