GW Pharmaceuticals plc (NASDAQ:GWPH) announced the European Medicines Agency (EMA) accepted its application for Epidiolex, a cannabidiol treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
As quoted in the press release:
This acceptance follows submission of the MAA in December 2017.
“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,” said Justin Gover, GW’s Chief Executive Officer. “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.