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Landmark UK Import Permit granted for MGC Pharma’s CannEpil+ (containing THC), designed to treat Refractory Epilepsy

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« 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. »

Roby Zomer, Co-founder and Managing Director of MGC Pharma

MGC Pharmaceuticals Ltd (‘MGC Pharma’ or ‘the Company’), a European based bio-pharma company specialising in the production and development of phytocannabinoid-derived medicines, is pleased to announce that CannEpil+, a Biosimilar effect-identical product of CannEpilTM, which is a phytocannabinoid treatment for Refractory (or drug-resistant) Epilepsy, has been approved for UK import by the Medicine and Healthcare products Regulatory Agency (MHRA), which was facilitated by its UK distribution and clinical access Partner, Elite Pharmaco., report MGC Pharmaceuticals Ltd

Key Highlights:*

  • CannEpil+, based on CannEpilTM, designed by MGC Pharma to treat Refractory Epilepsy, has been approved for import into the UK by the Medicines and Healthcare products Regulatory Agency via its UK distribution and clinical access partner Elite Pharmaco.*
  • This is the first time that an epilepsy treatment currently in a Clinical Trial process, and containing THC, has been approved by the authorities in the UK for import.*
  • Landmark milestone achieved by the Company in the UK, opening a key strategic market for its leading phytocannabinoid derived medicine.*
  • CannEpil+ will be made available for free on compassionate grounds to ten patients for six months, whose treatment will be monitored as part of an observational trial using a Data Collection App, provided by Alta Flora. This app will provide real time data on the efficacy of CannEpil+ to the regulatory bodies, and Doctor’s monitoring its effectiveness as a treatment.*
  • One of the most common serious neurological conditions, Epilepsy affects approximately 600,000 people in the UK, and ~50 million people worldwide,1 with approximately 33% of adults, and 20-25% of children, suffering from Refractory Epilepsy (or Drug Resistant Epilepsy) which cannot be controlled with traditional anti-seizure medication.*

CannEpil+ will initially be used to treat ten patients in the UK who suffer from Refractory Epilepsy. MGC Pharma will be providing CannEpil+ free of charge to these patients on compassionate grounds for six months. This is the first time that the UK authorities have approved an Epilepsy treatment that is on a clinical pathway (Phase IIB) containing THC.*

The approval to import CannEpil+ into the UK is in response to the urgent need of some patients to have access to a clinical product which has demonstrated its efficacy at treating Refractory Epilepsy, as well as its safety.*

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 Pharma expects that the results from the observational data collection program, together with the fact that CannEpilTM has historical clinical safety and efficacy data, and a Phase IIb Clinical Trial that is currently under negotiation with a UK NHS facility, will provide specialist neurologists and general practitioners with the confidence to prescribe CannEpilTM and CannEpil+ to patients in urgent need of treatment.*

MHRA Approval and Prescription Approval
Now officially approved for import into the UK, a doctor can issue a prescription for CannEpil+ for both adults and children. There are currently 10 patients who will have access to CannEpil+ on compassionate grounds, who will be the first to be prescribed the treatment.*

* original article

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*** ndlr. : –.

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