GW Pharmaceuticals plc (GWPH, GWP.L), a biopharmaceutical company, Wednesday announced that the European Medicines Agency or EMA has granted orphan designation to its investigational product Epidiolex (cannabidiol or CBD) in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
In addition to this orphan designation by the EMA, GW has been granted Fast Track designation by the U.S. Food and Drug Administration or FDA for Epidiolex in the treatment of Dravet syndrome as well as orphan designations in both Dravet syndrome and Lennox-Gastaut syndrome or LGS.
GW said it is about to commence a full clinical development program for Epidiolex in the treatment of both Dravet syndrome and LGS, working with leading pediatric epilepsy specialists across the U.S. The first Phase 2/3 clinical trial is due to commence in the coming weeks.
The EMA orphan designation is a status assigned to a medicine intended for use against a rare condition 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.
These incentives can include reduced fees and protection from competition once the medicine is placed on the market, the company noted.
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