GW Pharmaceuticals has received approval for Epidyolex®(cannabidiol) for the treatment of attacks associated with tuberous sclerosis complex (TSC) in the UK.
GW Pharmaceuticals, now part of Jazz Pharmaceuticals, has announced that the UK Medicine and Healthcare products Regulatory Agency (MHRA) has approved a new indication for Epidyolex® (cannabidiol); as adjunctive treatment of convulsions associated with tuberous sclerosis complex (TSC) for patients two years of age and older. Tuberous Sclerosis Complex (TSC) is a hereditary condition in which benign tumors develop in various places in the body.
Cannabidiol for treatment of tumors and epilepsy
“We are delighted with the MHRA's decision in this new indication, which represents a significant step forward for TSC patients in the UK,” said Chris Tovey, Executive Vice President at Jazz Pharmaceuticals.
Epidyolex, the first plant-based cannabis-based drug, has been approved by the US Food and Drug Administration (FDA) for use in the US and by the European Commission (EC) for use in the European Union (EU). It is an oral solution containing highly purified cannabidiol (CBD). The European Medicines Agency (EMA) has approved the drug for the treatment of seizures related to LGS, Dravet syndrome and TSC.
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