EU approves cannabis-based child epilepsy medicine
The first cannabis-based medicine for childhood epilepsy is expected to be available across Europe after its UK producer, GW Pharmaceuticals, received EU approval.
Cambridge-based GW announced that the European Medicines Agency (EMA) and the European Commission had approved Epidyolex for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome for sufferers aged two years and older.
The European approval of Epidyolex comes a month ahead of GW’s expectations.
The strawberry-flavoured cannabidiol oral solution that is taken twice a day and lacks any “high” associated with marijuana is now available across Europe.
Approximately 50,000 European children and youngsters have one of the two syndromes. This includes about 10,000 reported cases in the UK alone, suggesting the overall numbers for the whole of Europe could be higher.
The drug is already on the market in the US.
GW Pharmaceuticals is looking to expand its success with Epidiolex in the American market. In the second quarter, Epidiolex sales reached US$72 million, exceeding expectations.
The biotech company in August said more than 12,000 patients received the CBD oil since its launch last year.
GW’s chief operating officer, Chris Tovey, who is in discussion with European health authorities, said: “The [US] feedback has been incredibly positive.
“We are hoping to make it available for UK patients in the next couple of months.”
The UK’s NHS has already turned down Sativex, GW’s cannabis-based medicine for multiple sclerosis, because of its high price tag.
Justin Gover, GW’s CEO, said: “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.
“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.”
Side effects can include sleepiness, decreased appetite, diarrhoea, fever, fatigue and vomiting.
LGS or Dravet sufferers can experience multiple seizures per day, putting patients at high risk of falls and injury, and they often fail to respond to other treatment. Many patients die before they reach their early 20s.
Epidyolex was found to significantly reduce the frequency of seizures in patients with LGS and Dravet syndrome.
Impatient patients have been growing their own cannabis using legally purchased seeds. Picture credit: Eurasia Times