Clinically Trialled Medicinal Cannabis Product Could Be Given Final Approval In Two Months

Epidyolex, an oral solution of cannabidiol, has been recommended for approval for use as an add-on therapy for seizures associated with two severe forms of epilepsy beginning in childhood.

The plant-derived cannabis-based medicine has been recommended as a potential treatment option for children with Lennox-Gastaut syndrome or Dravet syndrome for children as young as two years old.

The medication, developed by GW Pharmaceuticals, would be used in conjunction with clobazam.

Worldwide approval

The US Food and Drug Administration (FDA) approved the oral solution last year.

Now the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has ‘adopted a positive opinion’ on the medication, recommending it for marketing authorisation.

The European Commission should make a final decision on its marketing authorisation application in about two months. A spokesperson for GW Pharmaceuticals said they were confident that approval and launch in the UK would not be affected by Brexit.
Read More