The MHRA approval allows the use of Epidyolex in England, Wales and Scotland, along with all 27 countries of the European Union, alongside Norway, Iceland and Liechtenstein
GW Pharmaceuticals, a subsidiary of Jazz Pharmaceuticals, has received regulatory approval for its cannabidiol product Epidyolex in the UK to treat a type of seizures.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) indicated the cannabidiol as an adjunctive treatment for seizures related to tuberous sclerosis complex (TSC) in patients aged two years and above.
TSC is a condition that causes benign tumours to grow in vital organs, including the brain, skin, heart, eyes, kidneys and lungs, with epilepsy as the most common neurological feature.
In September 2019, GW’s Epidyolex in combination with clobazam was authorised in the UK, as an adjunctive therapy to treat seizures related to Lennox Gastaut syndrome (LGS).
Also, the medicine has received a positive recommendation from the UK’s National Institute for Health and Care Excellence (NICE) in November 2019, for NHS England reimbursement.
GW said that the current approval of Epidyolex indicates the fourth approved indication for its cannabis-based medicine in the UK.
Jazz Pharmaceuticals Europe and international executive vice president, chief operating officer and managing director Chris Tovey said: “We are delighted by today’s decision from the MHRA for this new indication, which represents a significant step forward for TSC patients in the UK, many of whom may benefit from this new treatment.
“The UK is a significant country for us for many reasons, and we are proud to be able to offer a medicine that has been developed and is manufactured here, to even more patients across the UK.
“This authorisation, expanding the label, is further proof of our continued commitment to the UK and the pioneering research and development into regulatory approved cannabis-based medicines we have conducted here.”
The UK approval is carried out under the European Commission Decision Reliance Procedure (ECDRP) and is based on positive data from Phase 3 safety and efficacy study.
The trial evaluating 25 mg/kg/day of Epidyolex has met its primary endpoint with a seizure reduction of 49% in patients compared with 27% for placebo
In addition, all the key secondary endpoints are supportive of the effects on the primary endpoint.
GW’s cannabidiol showed a consistent safety profile with findings from previous studies, and no new safety risks were identified.
The MHRA approval allows the use of Epidyolex in England, Wales and Scotland, along with all 27 countries of the European Union, alongside Norway, Iceland and Liechtenstein (including Northern Ireland).