GW Pharmaceuticals Announces Epidiolex(R) 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 (Nasdaq: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 . 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.
Justin Gover, GW’s Chief Executive Officer
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 Infantile Spasms, each of which are severe infantile-onset, drug-resistant epilepsy syndromes. Additionally, GW has received Fast Track Designation from the FDA for Epidiolex in the treatment of Dravet syndrome.
The EMA orphan drug designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union must not be more than 5 in 10,000) and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life threatening or a chronically debilitating rare disease.
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in 31 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.
Original press release: http://ir.gwpharm.com/releasedetail.cfm?ReleaseID=1019184
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