On Monday, the UK-based GW Pharmaceuticals announced that it has been given the first-ever green light to market a CBD-based product derived from cannabis plants for patients with epilepsy in Europe.
The European Commission, which serves as the EU’s executive branch, granted the company approval to market Epidyolex, after the product was sanctioned by the European Medicines Agency in July, paving the way for its sale across the continent. Though, it is specifically for “adjunctive use in conjunction with clobazam,” a sedative.
Epidyolex, which is called Epidiolex in the US, where it was approved by the FDA last summer, is designed to complement treatment for patients with Lennox‑Gastaut syndrome or Dravet syndrome. The oral solution is meant to help patients who are at least two years old grapple with these two rare forms of epilepsy, which are characterized by high mortality rates, as well as multiple seizures throughout the day that put them at risk of falls and injuries.
According to GW Pharmaceuticals, with the Commission’s approval, Epidyolex will be made available among the countries that form part of the European Union, as well as Iceland, Liechtenstein, and Norway. The Commission’s approval, the company added, is based on results from four randomized, controlled Phase 3 trials involving 714 patients.
The product still faces some hurdles in the region.The United Kingdom’s National Institute for Health Research has prioritized research in areas relating to the use of cannabis-based products, including CBD for severe treatment-resistant epilepsy in children. However, in August, the National Institute for Health and Care Excellence (NICE) determined that the cost of Epidylox is too expensive to be provided by the national program.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said in a statement, “Even though the committee accepted that the evidence shows that cannabidiol with clobazam reduces seizure frequency, its long-term efficacy is unknown, and the committee was not convinced about the way the company had modelled the effect on people living longer or having a better quality of life. …
“However, we are committed to working with the company to resolve the economic modelling issues identified by the committee, and to help them understand what they may need to do to mitigate the cost of cannabidiol to the NHS.”
