GW Pharmaceuticals PLC – ADR (NASDAQ:GWPH) has garnered approval for the review of a new medication to treat seizure patients.
The European Medicines Agency (EMA) has accepted the biopharmaceutical’s request to review the Market Authorization Application (MAA) of Epidiolex, or cannibidiol. The medication is used to treat patients who suffer from seizures linked to Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
GW Pharmaceuticals first submitted Epidiolex for review on December 2017. CEO Justin Gover notes that the successful filing of the MAA of the drug follows the application acceptance by the U.S. Food and Drug Administration from December, as well as the 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,” he added.
The outcome of the MAA review by the EMA will be announced during the first quarter of 2019. GW Pharmaceuticals has been preparing itself for the commercialization of Epidiolex in Europe by hiring staff in its medical affairs area, as well as market access and marketing, all of which have experience with epilepsy or specialist disease.
The company has experienced considerable progress in hiring local medical staff and leadership in the five major European markets.
GWPH stock dropped 1.74% after the bell Monday.