EU regulator clears GW Pharmaceuticals' cannabidiol oral solution Epidyolex for Lennox‑Gastaut, Dravet syndrome

GW Pharmaceuticals said Monday that the European Commission approved 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 the cannabidiol oral solution is the first plant-derived cannabis-based medicine to be authorised in the EU.

The clearance of Epidyolex, which comes after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the drug in July, is based on data from four Phase III trials that included more than 714 patients with either LGS or Dravet syndrome. Results showed that when added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures.

The therapy was approved by the FDA in 2018 under the trade name Epidiolex for the same indication. GW Pharmaceuticals later stated that it would charge $32,500 annually for the product, with the US Drug Enforcement Administration eventually rescheduling the treatment from Schedule I to Schedule V, permitting its launch in the country.

However, last month, the National Institute for Health and Care Excellence issued draft guidance recommending against NHS reimbursement of Epidyolex, cautioning that because clinical trials had only assessed efficacy for 14 weeks, the long-term effectiveness of the drug in combination with clobazam remains uncertain. NICE, which is expected to issue final guidance in November, also noted at the time that GW Pharmaceuticals had not confirmed the list price of the drug with the UK Department of Health and Social Care.  

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