European Union Clears First Cannabis-Based Medicine

(Bloomberg) -- The European Union approved a cannabis-based treatment as a prescription drug for the first time, paving the way for its introduction across the continent.

Doctors can now prescribe GW Pharmaceuticals Plc’s Epidyolex to help alleviate the seizures caused by two rare and extreme forms of epilepsy that start in childhood, the Cambridge, England-based company said in a statement Monday. The drug comes as a drinkable liquid that contains a high dose of cannabidiol, an ingredient of the cannabis plant that doesn’t get users high.

The ruling comes after several countries on the continent move to legalize cannabis for medical use, including the U.K., Germany and Italy. In the U.S., the Food and Drug Administration granted approval for the GW medicine in June last year -- its first-ever nod to a pot-derived medicine.

“We believe patients and physicians deserve access to rigorously tested and evaluated cannabis-based medicines, manufactured to the highest standards and approved by medicines regulators,” Justin Gover, GW’s chief executive officer, said in the statement.

The two forms of epilepsy, called Dravet syndrome and Lennox‑Gastaut syndrome, start in childhood and cause multiple seizures a day, putting patients at high risk of falls and injury. They are resistant to existing anti-epileptic drugs. Epidyolex was approved for use in addition to the older anti-convulsion medicine clobazam.

--With assistance from James Paton.

To contact the reporter on this story: Ellen Milligan in London at emilligan11@bloomberg.net

To contact the editors responsible for this story: Eric Pfanner at epfanner1@bloomberg.net, Marthe Fourcade, Thomas Mulier

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