GW Pharmaceuticals submits Type II Variation Application to the European Medicines Agency in hopes to expand the use of EPIDYOLEX®, (cannabidiol) oral solution, for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC)
GW Pharmaceuticals plc, a world leader in discovering, developing and commercialising cannabinoid prescription medicines, today announces the submission of a Type II Variation Application to the European Medicines Agency (EMA) seeking approval of EPIDYOLEX®, (cannabidiol) oral solution, for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC), 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.
"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," Chris Tovey, GW's Chief Operating Officer.
"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."
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.1
The Type II Variation Application is based on data from a positive Phase 3 safety and efficacy study. The study met its primary endpoint with patients treated with GW's cannabidiol oral solution 25 mg/kg/day experiencing a significantly greater reduction from baseline in TSC-associated seizures compared to placebo (49% vs 27%; p=0.0009). Results for the 50 mg/kg/day dose group were similar, with seizure reductions of 48% from baseline vs 26.5% for placebo (p=0.0018).
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.
To learn more about GW Pharma visit their company HQ here.
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