GW Pharmaceuticals plc, a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the European Commission (EC) has approved the Type II variation application for EPIDYOLEX? (cannabidiol) as an adjunctive treatment of seizures associated with TSC, for patients two years of age and older. This approval, which represents the third indication for GW’s cannabidiol in Europe, paves the way for the expanded launch of the medicine across Europe.

“This is an exciting moment for patients, and their families, who are affected by this debilitating disease and may benefit from this treatment. This approval is the result of the continued dedication of GW and the physician and patient communities to address this serious unmet medical need,” said Justin Gover, GW’s Chief Executive Officer. “We now look forward to working with each European member state to make EPIDYOLEX? available to appropriate patients across Europe, as quickly as possible.”

Dr. Volker Knappertz, GW’s Chief Medical Officer, said, “We are excited by the news of this approval by the European Commission and the benefits EPIDYOLEX could bring to the community. The clinical data supporting EPIDYOLEX in TSC provides hope of a better quality of life for patients. This medicine provides more choice for physicians managing seizures associated with TSC and has the potential to benefit the thousands of patients who do not respond to the current standard of care.”

Professor Alexis Arzimanoglou, Coordinator of the European Reference Network for Rare and Complex Epilepsies ERN EpiCARE (University Hospitals of Lyon, France), added, “Those suffering from TSC and those involved in their care will welcome this European approval. Given the demonstrated efficacy and safety profile of EPIDYOLEX, this important development could offer a much-needed treatment option to those most in need.”

The approval is based on data from a positive Phase 3 safety and efficacy study evaluating 25 mg/kg/day of GW’s cannabidiol. The study met its primary endpoint, which was the reduction in seizure frequency compared to baseline of cannabidiol vs placebo, with seizure reduction of 49% in patients taking cannabidiol 25 mg/kg/day compared with 27% for placebo (p=0.0009). All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed was consistent with findings from previous studies, with no new safety risks identified.

TSC is a condition that causes mostly benign tumours to grow in vital organs of the body, including the brain, skin, heart, eyes, kidneys and lungs, and in which epilepsy is the most common neurological feature. TSC is typically diagnosed in childhood.

GW’s cannabidiol was originally approved by the European Medicines Agency (EMA) in September 2019 under the tradename EPIDYOLEX? as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older.

The EC decision is valid in all 27 countries of the European Union, alongside Norway, Iceland and Liechtenstein.