FDA advisory panel unanimously backs approval of GW Pharmaceuticals' Epidiolex

An FDA advisory committee on Thursday voted unanimously in favour of approval of GW Pharmaceuticals' Epidiolex (cannabidiol) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. The agency is set to make a decision on whether or not to approve Epidiolex by June 27.

GW chief executive Justin Gover remarked "we are pleased by the advisory committee's unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy." The company said that if cleared, the drug would be the first cannabis-derived therapy authorised in the US as well as the first FDA-approved therapy for Dravet syndrome. 

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The news comes after agency staff indicated that clinical data from three late-stage studies provided "substantial evidence" of the effectiveness of the drug. In study data unveiled in 2016, Epidiolex was shown to improve convulsive seizure frequency versus placebo in patients with Dravet syndrome. Trial results have also revealed that the therapy significantly reduce seizures versus placebo in patients with LGS.

Epidiolex was initially granted orphan drug status by the FDA in 2014 for use in patients with LGS. The drug has also received fast track and orphan drug designation from the agency for the treatment of Dravet syndrome.  

Analysts estimate that, if approved, the price of the therapy could be more than $25 000 annually.

For related analysis, see ViewPoints: No puff, all pass from FDA panel on Epidiolex.

 

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