Posted by Michael Wonder on 14 Mar 2020
GW Pharmaceuticals submits type II variation application to the EMA to expand the use of Epidyolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex
13 March 2020 - GW Pharmaceuticals today announces the submission of a Type II variation application to the EMA seeking approval of Epidyolex (cannabidiol) oral solution, for the treatment of seizures associated with tuberous sclerosis complex, a rare genetic condition and a leading cause of genetic epilepsy.
If approved, this will be the third licensed indication for GW’s cannabidiol oral solution in Europe.
The Type II variation application is based on data from a positive Phase 3 safety and efficacy study.
