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GW Pharmaceuticals medicine receives EMA's orphan drug status

The European Medicines Agency granted the orphan drug designation to GW Pharmaceuticals plc's Epidiolex to treat tuberous sclerosis.

Tuberous sclerosis is a rare genetic disorder that causes noncancerous tumors in the brain and other vital organs.

Epidiolex, or cannabidiol, is expected to undergo a phase 3 clinical trial as an adjunctive therapy for seizures associated with tuberous sclerosis.

GW Pharmaceuticals will make regulatory applications for the cannabis-based medicine in 2019, seeking approvals in U.S. and Europe.

The EMA's orphan designation is meant for medicines that target a rare condition which impacts no more than 5 in 10,000 people in the EU. It is meant to expedite development of a drug by offering incentives and protection from competition once the medicine is commercialized.

The treatment previously received orphan drug status from the U.S. Food and Drug Administration for the same indication.