BRIEF—EMA accepts filing for Epidiolex

UK cannabinoid drug specialist GW Pharmaceuticals says that the European Medicines Agency has accepted for review its Marketing Authorization Application (MAA) for Epidiolex (cannabidiol) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

This acceptance follows submission of the MAA in December 2017.

The outcome of the MAA review by the EMA is expected in first-quarter 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.