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GW Pharmaceuticals receives approval for EPIDYOLEX® (cannabidiol) from the MHRA for the treatment of seizures associated with tuberous sclerosis complex
It is estimated that between 3,700 and 11,000 people in the UK live with tuberous sclerosis complex (TSC)(1) TSC causes epilepsy in up to 85% of patients, and
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"It is estimated that between 3,700 and 11,000 people in the UK live with tuberous sclerosis complex (TSC)(1)\n TSC causes epilepsy in up to 85% of patients, and up to 60% of those patients do not respond to standard anti-seizure medicines(2),(3),(4)\n Approval in TSC represents a new indication for GW's cannabidiol in the UK\n\n\nLONDON, Aug. 10, 2021 /PRNewswire/ -- GW Pharmaceuticals (\"GW\"), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines and now part of Jazz Pharmaceuticals plc (Nasdaq: JAZZ), today announces that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a new indication for GW's cannabidiol as an adjunctive treatment of seizures associated with tuberous sclerosis complex (TSC), for patients two years of age and older.\nGW was initially granted marketing authorisation for this medicine in the UK in September 2019 as an adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. GW also received positive recommendation from the UK's National Institute for Health and Care Excellence (NICE) for this medicine in November 2019 to receive routine reimbursement from NHS England. This authorisation for TSC, represents the fourth approved indication of a cannabis-based medicine in the UK for GW and underlines GW's commitment to the UK and regulatory approved cannabis-based medicines. \n\"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,\" said Chris Tovey, Executive Vice President, Chief Operating Officer and Managing Director, Europe & International at Jazz Pharmaceuticals. \"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.\"\nCommenting on the MHRA approval of GW's cannabidiol, Tuberous Sclerosis Association (TSA) Chief Executive Louise ...