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news.The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
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Apart from the EMA orphan designation status, the company has also received fast track designation by the US Food and Drug Administration (FDA) for Epidiolex to treat Dravet syndrome as well as orphan designations in both Dravet syndrome and Lennox-Gastaut syndrome (LGS).
The company is currently working with leading pediatric epilepsy specialists across the US and is about to start a full clinical development program for Epidiolex in the treatment of both Dravet syndrome and LGS.
The first Phase II/III clinical trial is scheduled to begin in the coming weeks.
GW chief executive officer Justin Gover said Dravet syndrome represents a very substantial unmet need in Europe and a significant therapeutic challenge as many of the children suffering with this condition are resistant to current treatments and have exhausted all options.
"GW is now advancing a full clinical development program for Epidiolex in Dravet syndrome and looks forward to commencing this program in the coming weeks," Gover said.
"We believe that the clinical effect and safety data recently released on Epidiolex support GW’s confidence in the prospect of ultimately enabling children with Dravet syndrome around the world to have access to an approved prescription CBD medicine."
The company is focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform.
Image: GW Pharmaceuticals’ Dravet syndrome treatment Epidiolex gets EMA orphan status. Photo: courtesy of holohololand/ freedigitalphotos.net.