European Medicines Agency panel OKs GW Pharma’s cannabis drug

The Committee for Medicinal Products for Human Use (CHMP) recommended approval of the British company’s cannabis-based medicine Epidiolex, said the drug’s maker, GW Pharmaceuticals.

The CHMP is tasked with preparing the European Medicines Agency’s opinions on queries about the marketing of human medicines.

The CHMP opinion was adopted July 25, and the final decision now rests with the European Commission.GW Pharmaceuticals said it expects that to happen in two months.

Epidiolex was recommended “for use as adjunctive therapy of seizures” linked to Dravet syndrome or Lennox-Gastaut syndrome, in conjunction with the sedative Clobazam, for patients at least 2 years of age.

In June 2018, the U.S. Food and Drug Administration gave approval to a GW Pharmaceuticals CBD oral solution, marketed as Epidiolex, for the treatment of the same conditions.

This is the first time a plant-derived cannabis medicine received a positive opinion in the EU’s centralized procedure for approving medicines.

GW Pharma grows its own supply of cannabis in the United Kingdom and trades on the Nasdaq under the ticker symbol GWPH.