GW Pharmaceuticals, a biopharmaceutical company focused on making and selling therapeutics from its cannabinoid product platform, said Monday that the European Medicines Agency (EMA) will review its Marketing Authorization Application (MAA) for Epidiolex for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. This acceptance follows submission of the MAA in December 2017.
Justin Gover, GW’s Chief Executive Officer, said that EMA’s acceptance of the MAA is going along with the acceptance by the U.S. Food and Drug Administration of the Epidiolex New Drug Application in December, as well as the recent publication of Phase 3 LGS results in The Lancet.
Gover said GW will continue to build European commercial infrastructure as it waits future approval and launch of the new drug.
GW expects EMA’s answer in the first quarter of 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, the company said in the press release.
It added that 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,” the company said in its press release.
Pharmaceutical cannabis. Image: GW Pharmaceuticals