A significant milestone: CBD medication receives approval for use in the EU

24 Sep 2019 --- The European Commission (EC) has granted UK-based GW Pharmaceuticals (GW) marketing authorization for its cannabidiol (CBD) oral solution for patients with severe forms of epilepsy. Epidyolex is the first plant-derived cannabis-based medicine to be approved by the European Medicines Agency (EMA). CBD is currently considered an unauthorized novel food in the EU. But this news has been positively received as it may potentially pave the way for further regulatory clarity relating the use of CBD across pharmaceuticals and eventually, supplements and food and beverage.

“The approval of Epidyolex marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines. It is also the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” says Justin Gover, GW’s CEO. 

GW specializes in discovering, developing and commercializing CBD prescription medicines. Epidyolex is intended for use as adjunctive therapy of seizures associated with LGS or Dravet syndrome, for patients over two years, in conjunction with clobazam, a benzodiazepine and a psychoactive drug.

The EMA approval grants use in all 28 EU countries, as well as Norway, Iceland and Liechtenstein and clears the path for the use of the medicine across Europe. 

The medicine, however, has been approved for us by the US Food and Drug Administration (FDA) since June 2018.

Click to EnlargeThe EMA approval grants use in all 28 EU countries, as well as Norway, Iceland and Liechtenstein.“This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community. 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. We are the first to offer this solution to the epilepsy community,” Gover notes. 

Paving the way for further CBD use?
The news may be significant for more than just the medicine industry, as it could encourage regulatory approvals in the food and beverage sector as well. However caution is needed, as the European Food Safety Authority (EFSA) regulatory decisions concerning CBD are stalling and are yet to be announced. 

“Although this approval by the EMA may reinforce the interest in CBD in medicinal, food and recreational application, medicinal products are not the same as food products. This is true even if these different products are obtained from similar plant-based source material. Whereas a medicinal product aims to prevent or treat a disease, the primary function of a food product is its nutritional value. For CBD foods, there are potentially a number of functional effects,” Karin Verzijden, an Attorney-At-Law at Axon Lawyers, which specializes in food legislation, tells NutritionInsight.

“The EMA approval of Epidyolex will hopefully offer relief to children with early onset epilepsy. However, for the application of CBD in food, the field is still very much looking forward to the EFSA opinion with respect to the application for a Novel Food authorisation filed by Cannabis Pharma regarding a CBD food supplement. Although this opinion was due in March this year, not much has happened since in the sector,” she adds.

Previously, Verzijden told NutritionInsight that while the EU production and marketing of food products derived from Cannabis sativa L. has been considerably restricted since CDB food products were recently declared to be unauthorized novel foods, not all cannabis-derived food products require this authorization. Within this shifting regulatory space, companies are continuing to enter a market. 

Clinical trials support the approval
The approval of CBD oral solution is based on results from four randomized, controlled Phase 3 trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers, GW says.

Many patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at ongoing risk of falls and injury. Despite current anti-epileptic drug treatment, both of these severe forms of epilepsy remain highly treatment-resistant.

When added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome. The most common adverse reactions that occurred in patients treated with the medicine were somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting. GW’s development programme represents the only well-controlled clinical evaluation of a CBD medication for patients with LGS and Dravet syndrome.

“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy, with few patients achieving adequate seizure control,” notes Professor Elinor Ben-Menachem from the University of Gothenburg in Sweden. “The EMA approval will bring hope to patients and families, with the potential to better control seizures and improve quality of life.”

By Kristiana Lalou

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