Clinical GW Pharmaceuticals gets MHRA approval for Epidiolex to treat...

GW Pharmaceuticals gets MHRA approval for Epidiolex to treat TSC related seizures


A cannabinoid therapeutics developer and part of Jazz Pharmaceuticals plc., GW Pharmaceuticals, on August 10th, 2021, has announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for its drug, Epidiolex (cannabidiol), for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC) in the patients of age two and above.

Epidiolex helps treat seizures, which is an oral solution consisting of highly purified cannabidiol. Exceptional results yielded from the safety and efficacy data obtained from the phase III trials carried out by the European Commission Decision Reliance Procedure (ECDRP), paved way for the approval of the drug. 49% reduction in seizures had been noted among the patients using the said treatment. On the other hand, only 27% reduction was observed in the placebo group.

In different organs including brain, skin, kidneys, heart and eyes, the growth of benign tumors is usually caused by a rare genetic condition known as TSC, the severity of which can vary considerably. So according to the company, it has been a leading cause of the genetic epilepsy.

Louise Fish, Chief Executive Officer of Tuberous Sclerosis Association (TSA), 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 drug.”

He further added, “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 MHRA.”

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