GW Pharmaceuticals said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Epidyolex (cannabidiol) for use as adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. The company noted that if authorised, Epidyolex "will be the first plant-derived cannabis-based medicine to be approved in Europe for the treatment of any form of epilepsy."
The positive recommendation by the CHMP was supported by the results of four Phase III studies involving more than 714 patients with LGS or Dravet syndrome. Findings announced last November showed that Epidyolex significantly reduced seizure frequency in patients with Dravet syndrome, while similar data were also reported last year for the treatment of LGS.
The therapy gained clearance last year in the US, where it is sold as Epidiolex, for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age or older. Sales of the treatment reached $33.5 million in the first quarter.
For related analysis, see ViewPoints: Extra boost for already gangbusters-going Epidiolex.
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