Epidyolex Receives European Commission Approval

GW Pharmaceuticals - Epidyolex

GW Pharmaceuticals has announced it has received marketing authorisation for Epidyolex (not a typo) for treating certain conditions in all 28 EU countries as well as Norway, Iceland and Liechtenstein.

Epidyolex is probably better known (for now) as Epidiolex – the name it is marketed under in the USA and where it was approved for use in managing seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome by the US FDA in June last year.

Lennox‑Gastaut syndrome and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy.

Epidyolex/Epidiolex is based on cannabidiol (CBD), a non-intoxicating cannabinoid extracted from either hemp or medical cannabis.

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As in the USA, the European Commission (EC) has approved Epidyolex for treating Lennox‑Gastaut syndrome and Dravet syndrome – in conjunction with clobazam; a benzodiazepine commonly used in combination with other medications to treat seizures.

“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, and we are delighted to be the first to offer this solution to the epilepsy community,” said GW’s CEO, Justin Gover.

That offer will likely come with a significant cost attached. GW set a list price for Epidiolex in the USA last year that averaged out at around USD $32,500 per year of treatment. Whether the cost of the medicine has decreased since then and what the pricing will be in the EU isn’t clear.

In an update published last month, GW Pharmaceuticals said more 12,000 patients have received Epidiolex prescriptions since it was launched. If all those prescriptions were filled and treatment continued, that would translate to around $390,000,000 a year. However, Q2 2019 net sales were put at $68.4M – which is by no means shabby. The update notes the “vast majority” of patients who have received Epidiolex remain on the therapy.

The company said it expected to submit an sNDA (Supplemental New Drug Application) by the end this year seeking to expand Epidiolex’s use to include both children and adult patients with Tuberous Sclerosis Complex (TSC), a highly treatment-resistant condition.