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news.The European Medicines Agency (EMA) has accepted for review GW Pharmaceuticals' marketing authorization application (MAA) for Epidiolex (cannabidiol) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
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This acceptance follows submission of the MAA in December 2017.
GW CEO Justin Gover said: “The successful filing of the MAA for Epidiolex with the EMA builds on the momentum of acceptance by the U.S. Food and Drug Administration of the Epidiolex New Drug Application in December and recent publication of Phase 3 LGS results in The Lancet.
“We continue to build European commercial infrastructure in anticipation of future approval and launch with the goal of making this important new medicine available to appropriate patients and their caregivers, addressing the significant unmet need in LGS and Dravet syndrome, two rare and debilitating conditions of childhood-onset epilepsy.”
The outcome of the MAA review by the EMA is expected in Q1 2019. In preparation for the commercialization of Epidiolex in Europe, GW continues to hire staff in the areas of medical affairs, market access and marketing, all with strong epilepsy or specialist disease experience.
Significant progress has been made in hiring country leadership and local medical staff in the five major European markets. This European commercial effort is being led by Chief Operating Officer Chris Tovey, who has significant experience commercializing and launching pharmaceutical products, including within the field of epilepsy.