Further to our recent news article here, we can confirm that CBD based drug Epidyolex has received marketing approval by the EU commission.
Approval for the drug has been granted for in Lennox Gastaut & Dravet Syndromes in patients over two years old who are already prescribed Clobazam (Frisium). The marketing approval will apply to all EU member states, including Ireland.
The manufacturers of Epidyolex, GW Pharmaceuticals announced that they had received approval yesterday evening, with their Chief Executive Officer, Justin Glover commenting, “The approval of Epidyolex marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy. 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, and we are delighted to be the first to offer this solution to the epilepsy community.”
While Epidyolex can now be marketed in Europe, GW have previously indicated that their initial focus will be to launch the medication in the five biggest European countries. It is not clear currently if/when the company will launch in Ireland. Even when they do, the National Centre for PharmacoEconomics will be required to assess the drug to determine if it is to be reimbursed by the state or not. In the UK, the National Institute for Health and Care Excellence (NICE) recently announced that it would provisionally not recommend the drug for reimbursement by the NHS.
The full press release from GW Pharmaceuticals regarding this decision can be found here. Should you have any questions regarding the use of this drug, please consult with your Epilepsy Nurse Specialist or medical team.
We will continue to monitor the plans for this drug in Ireland and will provide further updates here and on our social media channels.
For more on medicinal cannabis in epilepsy, see: https://www.epilepsy.ie/content/medical-cannabis