Biopharmaceutical company MGC Pharmaceuticals has had its cannabinoid treatment for drug-resistant epilepsy approved for import in the UK by the Medicine and Healthcare products Regulatory Agency (MHRA)The import approval was given to MGC Pharma’s CannEpil+ product – a biosimilar to its CannEpil phytocannabinoid treatment for Refractory (or drug-resistant) Epilepsy.

The decision by the MHRA means that doctors UK in can now issue a prescription for CannEpil+ for both adults and children. CannEpil+ will initially be used to treat 10 patients in the UK who suffer from Refractory Epilepsy. The drug will be provided free of charge to patients on compassionate grounds for six months.  

Epilepsy is thought to affect around 600,000 people in the UK and is one of the most common serious neurological conditions in the world. 

Drug- resistant epilepsy occurs when seizures still occur after taking at least two anti-seizure medications (ASMs). It's estimated that epilepsy fails to come under control with medicines in around one third of adults and almost a quarter of children. 

CannEpil is still currently undergoing a Phase IIb clinical trial in Israel, where it is being tested as an add-on treatment for children and adolescents with Refractory Epilepsy. The MHRA’s decision marks the first time UK authorities have approved an Epilepsy treatment containing THC that is still currently on its clinical pathway.

Once the patients have commenced their treatment, CannEpil+ will undergo an observational trial with data being entered into a Data Collection App designed to establish a central platform to monitor the safety of treatment in patients globally.

MGC’s development of CannEpil as a biosimilar means it will be able to offer the treatment to patients at a more affordable price globally, as the company moves through the clinical trials process.

Roby Zomer, co-founder and managing director of MGC Pharma, commented: “The approval for the import of CannEpil+ to the UK and the associated compassionate prescriptions is an important step towards our global roll out of the treatment, and our continued commitment to patients. Achieving MHRA approval has been an ongoing process for some time with our UK partner Elite Pharmaco, and we expect the first patients in the UK to begin treat with CannEpil+ in the coming months.

“The development of our Data Collection App will optimise our understanding of both CannEpil, CannEpil+ and other future treatments, and ultimately provide patients with a better treatment for Refractory Epilepsy, and therefore improving their quality of life. It is also a vitally important foundation for building strong relationships with UK medical regulators and health organisations which will benefit MGC Pharma going forward, as we look to roll out further clinical trials and products in the UK.”

Robin Emerson COO of Elite Growth Ltd and high-profile Medical Cannabis Advocate commented: “This is a huge step forward for cannabis-based medications in the UK. As a father of a 5-year-old girl I have witnessed first-hand how Jorja’s life has been transformed by the use of a Cannabis based medication that contains THC. With this product approval patients that have tried everything else how have a product with some level of safety and efficacy for the treatment of epilepsy that can be prescribed by their physician. With the ongoing clinical trial portfolio that MGC Pharma have developed, including a near term UK NHS based trial, we are answering the call of clinicians in the UK who are asking for safety and efficacy data. The CannEpil+ programme we are executing will go a long way to moving cannabis-based medications toward greater adoption and acceptance, opening up much needed access for patients in the UK.”