GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) reported that its drug Epidiolex® has received Orphan Drug Designation from the European Medicines Agency. This status is granted in respect to the drug targeting Lennox-Gastaut Syndrome.
Justin Gover, the CEO of GW Pharmaceuticals, reported that following two promising Phase III studies of Epidiolex in subjects with LGS, the company is committed to opting for Epidiolex registration in Europe in order to offer these patients access to a permitted prescription CBD drug. Besides preparing to file a New Drug Application with the Food and Drug Administration this year, the company is also looking to file application with the EMA.
In addition to this status in LGS, GW Pharmaceuticals has previously been offered Orphan Drug Designation for Epidiolex in the cure of Dravet syndrome. In the United States, the company has obtained Orphan Drug Designation for Epidiolex in the cure of LGS, Tuberous Sclerosis Complex, Infantile Spasms and Dravet syndrome, each of which are grave infantile-onset, medicine-resistant epilepsy syndromes. Moreover, the company has obtained Fast Track Designation from the U.S. FDA for Epidiolex in the cure of Dravet syndrome.
The orphan drug designation is assigned to a drug intended for treating a rare condition and enables a pharmaceutical firm to gain from incentives provided by the EU to advance a drug for the diagnosis, treatment or prevention of a disease that is chronically debilitating or life threatening rare disease.
As the cannabis business continues to turn into a lucrative industry, investors, industry advocates and entrepreneurs are recognizing major opportunities to capitalize on the trend and steadily growing revenues. GW Pharmaceuticals comes in the list of those notable firms that are constantly taking steps to cash-on this growth. Considering impressive sales of recreational and medical cannabis that grew by 30% in 2016, it comes as no surprise why investors are flocking to cannabis sector to claim their interest in the industry.