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EU approval of oral Cannabidiol as an adjunct to dravet syndrome

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Epidiolex from GW Pharma approved by the European Medicines Agency

The Committee for Medicinal Products for Human Use (CHMP), an agency of the European Medicines Agency (EMA), recommends the approval of the oral solution of cannabidiol from GW Pharmaceutical in addition to clobazam (Onfi and Sympazan) for the treatment of convulsions in children and adults of 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 of the British company Epidiolex. The CHMP is responsible for preparing the opinions of 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 adjunctive therapy for convulsions" related to Lennox-Gastaut syndrome or Dravet syndrome, in combination with sedative clobazam, in patients aged at least 2.

The CHMP based its recommendation on the results of four randomized, controlled phase 3 controlled trials. The European Commission (EC) will now consider the CHMP's favorable opinion on Epidyolex, approved in the United States under the trademark 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 under the name Epidiolex, for the treatment of the same conditions. This is the first time that a plant-based cannabis drug receives a favorable opinion as part of the centralized procedure approval of EU medicines.

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

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

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 act on brain receptors and, when defective, can cause seizures.

The CHMP's positive opinion today on Epidiolex marks a milestone for patients and their families 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, CEO of GW, in a statement.

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

The results of the extension study showed that treatment with Epidiolex reduced seizures from 38% to 44% and all attacks from 39% to 51%. Its use has also improved the overall health and clinical status of about 80% of patients after six months and one year of treatment.

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"This is an important step for patients with LGS and Dravet syndrome because 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 view gives hope to patients and their families about 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 in therapeutic failure, often very resistant to existing treatment. These patients and their families are facing a long and difficult road and very few of them manage to cope with their seizures, "said Antonio Gil-Nagel Rein, director of the epilepsy program at Ruber International Hospital in Madrid. "According to many clinical trials and the scrutiny of the European Medicines Regulatory Agency, 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 (SPC), which will be published in the European public evaluation report (EPAR) and made available in all the official languages ​​of the European Union after the marketing authorization has been granted by the European Commission.

Tags : DravetEpidiolexSyndromeTreatment