GW Pharmaceuticals, which is part of Jazz Pharmaceuticals plc (NASDAQ: JAZZ), has announced the approval of a new indication for EPIDYOLEX (cannabidiol) by the UK Medicines Healthcare Products Regulatory Agency (MHRA). MHRA approved the cannabidiol as adjunctive therapy for seizures related to tuberous sclerosis complex for patients above two years.
EPIDYOLEX received approval in 2019
In September 2019, GW received marketing authorization in the UK for this medicine as an additional therapy for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in combination with clobazam, in patients aged two and up. In November 2019, the National Institute for Health and Care Excellence (NICE) in the United Kingdom recommended that GW obtain routine payment from NHS England for this drug. TSC is GW’s fourth approved indication of a cannabis-based drug in the UK, demonstrating the company’s dedication to the UK and regulatory-licensed cannabinoid medicines.
Jazz CEO 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.”
Approval giving TSC people an alternative treatment
Tuberous Sclerosis Association CEO Louise Fish said, “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 people living with TSC and their families hope. We desperately need further options for clinicians who are managing seizures associated with TSC, and we therefore welcome this decision by the MHRA.”
