EMA grants Orphan Drug Designation to GW Pharmaceuticals’ Epidiolex


The European Medicines Agency (EMA) has granted Orphan Drug Designation to UK-based GW Pharmaceuticals’ investigational product Epidiolex (cannabidiol or CBD) to treat Lennox-Gastaut Syndrome (LGS).

LGS is a treatment-resistant, debilitating, childhood-onset epilepsy.

The EMA orphan drug designation is assigned to a medicine intended for use against a rare condition.

The designation also allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a life threatening or a chronically debilitating rare disease.

"In addition to preparing to submit a New Drug Application with the US Food and Drug Administration in the middle of 2017, we are also planning a submission to the EMA shortly afterwards."

GW Pharmaceuticals CEO Justin Gover said: "Following two positive Phase III 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.

"In addition to preparing to submit a New Drug Application with the US Food and Drug Administration in the middle of 2017, we are also planning a submission to the EMA shortly afterwards.”

GW previously secured Orphan Drug Designation from the EMA for Epidiolex to treat Dravet syndrome.

In the US, the designation was granted for Epidiolex with the treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex, and Infantile Spasms.

Epidiolex additionally secured Fast Track Designation from the FDA for the treatment of Dravet syndrome.