EU approval of oral Cannabidiol as an adjunct to dravet syndrome

GW Pharma's Epidiolex approved by the European Medicines Agency

The Committee for Medicinal Products for Human Use (CHMP), a body of the European Medicines Agency (EMA), recommends the approval of GW Pharmaceutical's cannabidiol oral solution in addition to clobazam (Onfi and Sympazan) for the treatment of seizures in children and adults 2 years and older with Dravet syndrome or Lennox-Gastaut syndrome.

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GW Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the cannabis-based drug from the British company Epidiolex. The CHMP is responsible for preparing opinions from the European Medicines Agency (EMA) on issues related to the marketing of medicinal products for human use. Epidiolex has been recommended "for use as an adjuvant treatment of seizures" associated with Lennox-Gastaut syndrome or Dravet syndrome, in combination with sedative clobazam, in patients 2 years of age or older.

The CHMP based its recommendation on the results of four randomized, controlled phase 3 controlled trials. The European Commission (EC) will now consider the favorable opinion of the CHMP on Epidyolex, approved in the United States under the brand Epidiolex which has been adopted the 2 July 2005 and the final decision now lies with the European Commission, which GW Pharma expects in about two months.

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In June 2018, the US Food and Drug Administration approved  a CBD oral solution from GW Pharmaceuticals, marketed as Epidiolex, for the treatment of the same conditions. This is the first time that a herbal cannabis medicine has received a favorable opinion as part of the centralized procedure  for EU drug approval.

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Sativex, another GW Pharma product, is available in several European countries but not everywhere in Europe. In Germany, sales of medical cannabis covered by insurance represent almost 20% of the market.

GW Pharma develops its own cannabis stocks in the UK and trades on Nasdaq under the symbol  GWPH .

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Epidiolex is a purified form of cannabidiol (CBD), the most abundant non-psychoactive cannabinoid compound in the cannabis plant. CBD can mimic natural compounds that work on receptors in the brain and which, when faulty, can cause seizures.

Today's positive opinion from the CHMP on Epidiolex marks an important milestone for patients and their families, who are struggling to control two of the most serious and deadly forms of childhood epilepsy. Cannabidiol oral solution is the first in a new class of epilepsy drugs and the first plant-based cannabis drug to undergo European regulatory review, a historic breakthrough, said Justin Gover, chief executive of GW, in a statement.

The CHMP's decision is based on data from a clinical development program that included three randomized controlled phase 3 clinical trials (NCT02091375, NCT02224703 and NCT02224560), and one open-label extension study (NCT02224573). The latter evaluated the safety and long-term efficacy of the solution and included 189 Dravet patients from two of the previous phase 3 trials.

The results of the extension study showed that treatment with Epidiolex reduced seizures by 38% to 44% and all seizures by 39% to 51%. Its use also improved the general health and clinical condition of around 80% of patients after six months and one year of treatment.

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"This is an important milestone for patients with LGS and Dravet syndrome, as these rare and permanent forms of epilepsy still have serious unmet medical needs," said Martin Brodie, President of the International Bureau epilepsy. “Today's positive opinion gives patients and their families hope for a treatment option that has the potential to better control seizures and dramatically improve quality of life.

“In my clinic, I often see patients with these forms of epilepsy failing treatment, often very resistant to existing treatment. These patients and their families face a long and difficult road and very few of them manage to bring their seizures under control, ”said Antonio Gil-Nagel Rein, director of the epilepsy program at Ruber International Hospital in Madrid. “Based on extensive clinical trials and scrutiny from the European Medicines Regulator, this drug has the potential to make a real difference in the lives of many patients. "

Epidiolex has been approved by the United States Food and Drug Administration (FDA) for the treatment of patients with Dravet syndrome and Lennox-Gastaut, aged 2 years and older, in June 2018.

Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official languages ​​of the European Union after the marketing authorization has been granted by the European Commission.

Tags : DravetEpidiolexSyndromeTreatment
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