Health Canada has approved Jazz Pharmaceuticals’s Epidiolex (cannabidiol oral solution) as an adjunct therapy in patients aged two years and older for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC).
Epidiolex is a plant-based oral cannabidiol solution. It was developed by GW Pharmaceuticals and was added to Jazz’s portfolio following GW’s acquisition in 2021. The therapy was first approved in the US as an adjunct therapy in patients aged two years and older for the treatment of seizures associated with LGS and Dravet syndrome in June 2018. The approval in TSC came in July 2020.
All three indications causes different types of serizure. LGS and Dravet syndrome are types of epileptic encephalopathy, that cause seizures. LGS is managed by two or more seizure medications whilst Dravet is treatment-resistant.
TCS is a rare genetic condition that causes benign tumours to develop in different parts of the body, including the brain and spinal cord. Epilepsy is commonly associated with TCS.
The Health Canada approval was based on the results from five Phase III clinical trials, as per a 23 November press release. Of these, two trials (NCT02091375 and NCT02224703) were conducted in patients aged 2-18 years with Dravet syndrome. Two studies (NCT02224560 and NCT02224690) evaluated Epidiolex in LGS patients aged 2-55 years. A study (NCT02544763) evaluated the drug in TCS patients aged 1-65 years. All the trials met their primary endpoints.
The commonly observed side effects of Epidiolex include diarrhoea and vomiting. The use of Epidiolex is also cautioned in geriatric patients as this patient group has not been studied in clinical trials.
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Jazz also plans to secure reimbursement for Epidiolex in Canada following the approval, as per the 23 November press release. Epidiolex generated $213.7m in sales in Q3 FY 2023, as per Jazz’s Q3 financials. The drug is forecasted to generate $1.5bn in global sales in 2029, as per GlobalData analysis.
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Jazz is conducting a pivotal Phase III trial for Epidiolex in patients with seizures associated with the three conditions in Japan. The top-line data from the study is expected in H2 2024, as per an 8 November press release. The company is also planning multiple global launches for the drug through 2024.
Recently, Jazz partnered with GSK spin-out Autifony Therapeutics to discover and develop neurological drugs, which target two ion channel targets linked to these indications. As per the agreement, Autifony would bear responsibility for pre-clinical development while Jazz would take up the clinical, regulatory and marketing responsibilities.