CBD-based drug moves closer to authorisation in Europe

The Human Medicines Committee of the European Medicines Agency have recently granted a positive opinion regarding the use of cannabidiol (CBD) based drug Epidyolex (spelled as Epidiolex in the US) in two forms of epilepsy.

As part of their July meeting, the committee recommended marketing approval for the drug in Lennox Gastaut & Dravet Syndromes in patients over two years old who are already prescribed Clobazam (Frisium).

The positive opinion was based on the results of four randomised controlled clinical trials involving over 700 patients. The drug was approved by the US FDA in 2018.

While this brings authorisation a step closer, final approval will have to be given by the European Commission before the drug can be officially marketed. This decision is expected in September 2019 and generally speaking, the European Commission follows the recommendations of the Committee.

Epilepsy Ireland will continue to monitor this matter and post updates on both our website and our social media channels. Once approved, we will work to ensure access to the medication and its reimbursement in Ireland.

Should you have any further questions regarding this drug, please consult with your medical team.

Further information regarding the Committee’s recommendation can be found here:

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/epidyolex

 

For more on medicinal cannabis in epilepsy, see: https://www.epilepsy.ie/content/medical-cannabis