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The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.
On August 10, 2021, GW Pharmaceuticals, a pharmaceutical developer specializing in cannabis-based medical treatment and part of Jazz Pharmaceuticals plc, announced it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the use of Epidiolex (cannabidiol) in the United Kingdome for the treatment of seizures associated with tuberous sclerosis complex (TSC) for patients two years of age and older.
Epidolex is an oral solution consisting of highly purified cannabidiol for use in the treatment of seizures. It was approved for the new indication following positive results from a Phase III safety and efficacy study from the European Commission Decision Reliance Procedure (ECDRP) that evaluated 25 mg/kg/day. There was a 49% reduction in seizures in patients taking Epidiolex compared to 27% who took a placebo.
TSC is a rare genetic condition that causes mostly benign tumors to grow in organs such as the brain, skin, heart, eyes, kidneys, and eyes. While the severity of the condition can vary greatly, it is a leading cause of genetic epilepsy, according to the company.
"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,” said Tuberous Sclerosis Association (TSA) Chief Executive Louise Fish. “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."
Source: Jazz Pharmaceuticals