EMA to review Marketing Authorisation of GW Pharma’s cannibidiol
EMA has accepted GW Pharmaceuticals’ request to review the MMA (Marketing Authorisation Application) of Epidiolex, or cannibidiol.
The treatment is currently used on patients who suffer from seizures linked to Lennox-Gastaut syndrome and Dravet syndrome.
GW Pharmaceuticals first submitted Epidiolex for review in December 2017. The successful filing of the MAA of the drug follows the application acceptance by the FDA from December, as well as the recent publication of Phase 3 LGS results in The Lancet.
The outcome of the MAA review by the EMA will be announced during the first quarter of 2019. The biopharmaceutical company has been preparing itself for the commercialisation of Epidiolex in Europe by hiring staff in its medical affairs area, as well as market access and marketing, all of whom have experience with epilepsy or specialist disease.
CEO Justin Gover said: “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.”