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UK epilepsy drug set to be first cannabis-based medicine on US market UK epilepsy drug set to be first cannabis-based medicine in US
(about 1 hour later)
A treatment for childhood epilepsy developed by a UK firm is expected to be approved by US regulators this week, becoming the first cannabis-based medicine on the American market.A treatment for childhood epilepsy developed by a UK firm is expected to be approved by US regulators this week, becoming the first cannabis-based medicine on the American market.
Epidiolex, made by GW Pharmaceuticals, is expected to receive official approval from the US Food and Drug Administration by Wednesday and the drug would then be launched in the US in the autumn. It should be available to prescribe by doctors in Britain and the rest of Europe by mid-2019 if the European Medicines Agency gives it the nod early next year.Epidiolex, made by GW Pharmaceuticals, is expected to receive official approval from the US Food and Drug Administration by Wednesday and the drug would then be launched in the US in the autumn. It should be available to prescribe by doctors in Britain and the rest of Europe by mid-2019 if the European Medicines Agency gives it the nod early next year.
The UK home secretary has just launched a review into medicinal uses of cannabis following public pressure from the families of two sick children: 12-year-old Billy Caldwell and six-year-old Alfie Dingley, who have forms of intractable epilepsy that appear to be eased by the use of cannabis oil.The UK home secretary has just launched a review into medicinal uses of cannabis following public pressure from the families of two sick children: 12-year-old Billy Caldwell and six-year-old Alfie Dingley, who have forms of intractable epilepsy that appear to be eased by the use of cannabis oil.
GW’s chief executive, Justin Glover, stressed that Epidiolex was a prescription drug that had been shown to be effective in reducing seizures in clinical trials. “Cannabis oils are a very different thing. There’s no regulation, no quality control and no information on dose and side effects.” Glover said if GW was approached by the two boys’ physicians to request Epidiolex, the firm would be able to assist. GW’s chief executive, Justin Gover, stressed that Epidiolex was a prescription drug that had been shown to be effective in reducing seizures in clinical trials. “Cannabis oils are a very different thing. There’s no regulation, no quality control and no information on dose and side effects.” Gover said if GW was approached by the two boys’ physicians to request Epidiolex, the firm would be able to assist.
Epidiolex is a purified form of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant. It contains less than 0.1% of tetrahydrocannabinol (THC), which makes people high.Epidiolex is a purified form of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant. It contains less than 0.1% of tetrahydrocannabinol (THC), which makes people high.
The oral solution, which has a strawberry flavour and is taken twice a day, was developed by GW, which is based in London and Cambridge, employing 500 people in the UK, but is listed on Nasdaq.The oral solution, which has a strawberry flavour and is taken twice a day, was developed by GW, which is based in London and Cambridge, employing 500 people in the UK, but is listed on Nasdaq.
The firm has had a Home Office licence to grow cannabis for the past two decades, initially at secret farms in southern England and since 2016 at British Sugar’s 18-hectare glasshouse in Norfolk, and two other glasshouses. The cannabis is then moved to a secret location in the UK where CBD is extracted and purified, and made into a medicine. The firm has had a Home Office licence to grow cannabis for the past two decades, initially at secret farms in southern England and since 2016 at British Sugar’s 18-hectare glasshouse in Norfolk, and two other glasshouses. The cannabis is moved to a secret location in the UK where CBD is extracted and purified, and made into a medicine.
More than 50 children in the UK have already been treated with the medicine free of charge out of 1,500 worldwide, mostly in the US, on a compassionate access programme.More than 50 children in the UK have already been treated with the medicine free of charge out of 1,500 worldwide, mostly in the US, on a compassionate access programme.
It is designed for the treatment of patients from the age of two with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), which have a higher mortality rate than other types of epilepsy and do not respond to many of the other epilepsy drugs available.It is designed for the treatment of patients from the age of two with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), which have a higher mortality rate than other types of epilepsy and do not respond to many of the other epilepsy drugs available.
The most common side effect of Epidiolex is drowsiness. While the data shows that the drug could lead to liver injury, an advisory panel at the FDA said in April it was confident this could be managed with a warning label and monitoring.The most common side effect of Epidiolex is drowsiness. While the data shows that the drug could lead to liver injury, an advisory panel at the FDA said in April it was confident this could be managed with a warning label and monitoring.
Glover was tight-lipped about the likely price tag. Analysts expect the drug to become GW’s first “blockbuster” medicine with annual sales of more than $1bn (£756m). Around 30,000 people suffer from LGS and 6,000 from DS in the US, with similar numbers across Europe. Glover said GW had enough capacity to provide treatment for all of them. Gover would not reveal the likely price tag. Analysts expect the drug to become GW’s first “blockbuster” medicine with annual sales of more than $1bn (£756m).
GW, founded in 1998 by scientist Geoffrey Guy, now chairman, and fellow biotech entrepreneur Brian Whittle, initially developed Sativex, a mouth spray for multiple-sclerosis-related spasticity, which became the first cannabis-based medicine to be licensed in Britain. Around 30,000 people suffer from LGS and 6,000 from DS in the US, with similar numbers across Europe. Gover said GW had enough capacity to provide treatment for all of them.
GW – which was founded in 1998 by the scientist Geoffrey Guy, who is now chairman, and a fellow biotech entrepreneur, Brian Whittle – initially developed Sativex, a mouth spray for multiple-sclerosis-related spasticity, which became the first cannabis-based medicine to be licensed in Britain.
The company then started scientific work on CBD as a treatment to reduce seizures. In December 2012, GW was approached by the family of Sam Vogelstein, then 11, who was suffering from severe epilepsy. The boy was given purified CBD, which later became Epidiolex, and has been seizure-free for more than two years. He testified to the FDA panel.The company then started scientific work on CBD as a treatment to reduce seizures. In December 2012, GW was approached by the family of Sam Vogelstein, then 11, who was suffering from severe epilepsy. The boy was given purified CBD, which later became Epidiolex, and has been seizure-free for more than two years. He testified to the FDA panel.
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