LONDON and CARLSBAD, Calif., Dec. 28, 2017 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Epidiolex® (cannabidiol or CBD), an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018.
Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapies exist. The granting of Priority Review for the Epidiolex NDA accelerates the timing of the
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