GW Pharma wins US orphan status for tuberous sclerosis complex drug

Gaining orphan status can smooth a drug's path to full approval and can entitle a drug to a seven-year exclusive marketing period.

The London- and Nasdaq-listed company's cannabidiol (CBD) drug was given the designation by the Food and Drug Administration (FDA) for the treatment of tuberous sclerosis complex (TSC), the most common symptom of which is epilepsy.

TSC is the third orphan indication that GW is targeting within its Epidiolex clinical development program, which includes four Phase III trials in Dravet syndrome and Lennox-Gastaut syndrome, both rare and catastrophic forms of childhood-onset epilepsy.

Earlier this month GW announced it had begun a Phase III clinical trial of Epidiolex as an adjunctive therapy for the treatment of seizures associated with TSC.