The Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that Epidyolex® (cannabidiol) is safe and effective for TSC-related epilepsy in people aged two years and older. The approval means that decision-makers in the different UK nations can now consider whether to fund the medicine.
The MHRA’s decision is a pivotal moment in efforts to get access to cannabidiol for the TSC community in the UK. Decision-makers in the different UK nations must now consider whether to fund the medicine – these are: The National Institute for Health & Care Excellence (NICE, for approval and use by NHS England), the Scottish Medicines Consortium, the Welsh Specialised Services Team and the Department of Health, Social and Public Safety (Northern Ireland). The TSA is hopeful that some bodies will reach a decision by early 2022.
The TSA is delighted that the MHRA came to this positive decision, which potentially means that the TSC community in the UK will get access to this important treatment option in the future. The charity worked closely with stakeholders during the decision process to emphasise the importance of cannabidiol as a treatment option in TSC-associated epilepsy, and is already preparing to further campaign for approval of use in the different UK nations.
Louise Fish (TSA Chief Executive) commented: “One in every two people living with TSC-related epileptic seizures has difficult to treat epilepsy that does not respond to traditional anti epileptic drugs. We are excited to see this new medicine approved by the MHRA, which gives TSC patients and their families hope of a better quality of life. We desperately need further options for clinicians managing seizures associated with TSC, and this medicine has the potential to benefit those patients who do not respond to the current standard of care.”
Epidyolex® has already received licensing or marketing approval in some countries and regions, including the United States and the European Union (through the European Commission).
GW Pharmaceutical’s press release can be found here.
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