GW Pharma’s cannabidiol gains EC approval

pharmafile | April 21, 2021 | News story | Research and Development EC, EU, cannabis 

GW Pharmaceuticals has received European Commission (EC) approval for the type II variation application for Epidyolex (cannabidiol), as an adjunctive treatment of seizures associated with tuberous sclerosis complex (TSC) for patients two years of age and older.

This is the third indication of GW’s cannabidiol in Europe, and is based on data from a positive Phase III safety and efficacy study evaluating 25mg/kg/day of Epidyolex. 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 compared with 27% for those taking a placebo.

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. It is mostly diagnosed in childhood and has an estimated prevalence in the EU of 10 in 100,000.

The onset of epilepsy in TSC often occurs in the first year of life with patients initially suffering from predominantly focal seizures or infantile spasms. It is associated with an increased risk of autism and intellectual disability.

Justin Gover, GW’s Chief Executive Officer, said: “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.

“We now look forward to working with each European member state to make Epidyolex available to appropriate patients across Europe, as quickly as possible.”

GW’s cannabidiol was originally approved by the EMA in September 2019, under the name Epidyolex, as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome 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.

Dr. Volker Knappertz, GW’s Chief Medical Officer, said: “We are excited by the news of this approval by the EC 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.”

 Kat Jenkins

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