GW Pharma Submits CBD Seizure Treatment To European Medicines Agency For Approval

GW Pharmaceuticals plc GWPH said Friday it has submitted a Type II Variation Application to the European Medicines Agency, applying for authorization of its Epidyolex — Epidiolex in the U.S. — cannabidiol oral solution for the management of seizures related to tuberous sclerosis complex.

Tuberous sclerosis complex is known as a dominant cause of genetic epilepsy. It induces the growth of benign tumors in the brain, heart, lungs, kidneys, skin and eyes, with epilepsy being the most frequent neurological component, the company said.

If GW Pharma obtains approval, it would mark the third licensed indication for Epidyolex. 

“This submission to the EMA is an important step for GW and furthers GW’s mission to bring innovative cannabinoid medicines to patients with high unmet need,” Chief Operating Officer Chris Tovey said in a statement.

“We look forward to working with the EMA to demonstrate GW’s cannabidiol oral solution’s potential in this new indication and hope to make this rigorously tested cannabis-based medicine available to a new group of patients through a potential approval in due course.”

A positive Phase 3 safety and efficacy study showed that patients who were administered Epidyolex  had a considerable reduction in TSC-related seizures versus placebo, at 49% vs. 27%, according to GW Pharma. 

So far, the study hasn’t revealed any safety risks.

GW Pharma shares were trading 6.5% higher at $81.48 at the time of publication Friday. 

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Photo courtesy of GW Pharma.