Epidyolex has been recommended for approval for use as an add-on therapy for seizures associated with two severe forms of epilepsy beginning in childhood. GW Pharmaceuticals’ cannabis-based treatment, an oral CBD solution, won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel on Friday for use as an additional treatment for two types of seizures. CBD has been know to help epilepsy in adults and children.
Testing approved by European Medicines Agency
EMA’s human medicines committee (CHMP) cleared the Epidyolex for use with clobazam to treat seizures associated with Lennox‑Gastaut syndrome or Dravet syndrome for patients aged two and older. The CHMP’s positive opinion is based on results from four randomised, controlled Phase III trials, the company said.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months. GW expects a final decision in about two months.
News warmly welcomed by academia
The news was warmly welcomed by Ley Sander, Professor of Neurology at UCL and Medical Director at Epilepsy Society, saying: “This is good news for children with some of the most serious forms of epilepsy.”
“Epidyolex has been clinically trialled to prove its efficacy and safety so, where appropriate, physicians will be able to prescribe it in the knowledge that there is evidence to support its use.”
“Epidyolex has been through extensive clinical trials and although not a magic bullet, we know that it may work for some children whose seizures do not respond to current treatment options. But like all anti-seizure drugs, it would seem that Epidyolex may work for some children but not for others.” CBD is a option for many suffering from seizures.
Last year, the drug became the first cannabis-based medicine to be approved in the United States under the brand name Epidiolex after regulators permitted the treatment for two other forms of childhood epilepsy.
The U.S. Drug Enforcement Administration has labelled the drug as having a low abuse potential. Analysts at Cantor Fitzgerald said they don’t anticipate the need for the treatment to be co-administered with clobazam to be an issue.
“Given the high unmet medical need for these patients in EU, we expect the drug will be prescribed broadly.” They predict the treatment will launch in 2020 with initial sales of about $80 million and peak Europe sales of about $500 million.
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