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GW Pharmaceuticals Announces Epidiolex® Receives Orphan Drug Designation from the European Medicines Agency for the Treatment of Lennox-Gastaut Syndrome

LONDON, March 29, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPH) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to GW’s investigational product Epidiolex® (cannabidiol or CBD) in the treatment of Lennox-Gastaut Syndrome (LGS), a treatment-resistant, debilitating childhood-onset epilepsy.

"Following two positive Phase 3 trials of Epidiolex in patients with LGS, GW is committed to pursuing registration of Epidiolex in Europe in order to provide these patients access to an approved prescription CBD medicine," stated Justin Gover, GW's Chief Executive Officer. "In addition to preparing to submit a New Drug Application with the U.S. Food and Drug Administration in the middle of 2017, we are also planning a submission to the EMA shortly afterwards.”

In addition to this Orphan Drug Designation by the EMA in LGS, GW has also previously been granted Orphan Drug Designation by the EMA for Epidiolex in the treatment of Dravet syndrome. In the U.S., GW has received Orphan Drug Designation from the FDA for Epidiolex in the treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex, and...