Medical and PharmaceuticalNewsRegulationsU.K. approves 2 cannabis-based medicines

The medicines, made by GW Pharmaceuticals, are prescribed to treat severe childhood-onset epilepsy and spasticity caused by multiple sclerosis
Michelle Gamage Michelle GamageNovember 13, 20194 min

Two cannabis-based medicines made by GW Pharmaceuticals (NASDAQ: GWPH) used to treat severe epilepsy and multiple sclerosis in children have been approved for use by the United Kingdom’s National Health Service.

This is the first time the U.K.’s National Institute for Health and Care Excellence (NICE) has recommended pot-products for patients.

“This is a momentous occasion for U.K. patients and families who have waited for so many years for rigorously tested, evidenced and regulatory approved cannabis-based medicines to be reimbursed by the NHS,” GW chief operating officer Chris Tovey said in a statement. “This is proof that cannabis-based medicines can successfully go through extensive randomized placebo-controlled trials and a rigorous NICE evaluation process to reach patients.”

Epidyolex is a US Food and Drug Administration-approved purified cannabidiol (CBD) prescribed to patients aged two years and older. The strawberry-flavoured medicine is taken twice a day to treat seizures associated with Lennox Gastaut syndrome (LGS) and Dravet syndrome, which are rare but severe early-onset conditions resistant to other treatments. Epidyolex is designed to be taken in addition to other anti-epileptic therapies to reduce seizures.

Sativex is the world’s fist cannabis prescription medicine which is used to help treat spasticity caused by multiple sclerosis, and is approved for use in 25 countries around the world.

In Europe, there are roughly 103,000 patients affected by LGS and 26,000 patients affected by Dravet syndrome, according to the European Medicines Agency.

In September, the European Union green lit the sale of Epidyolex in all of its 28 countries, as well as Norway, Iceland and Liechtenstein, but the U.K. government did not recommend the drug at that time.

In a press release by GW Pharmaceuticals, Rhys Thomas, a consultant neurologist at the Royal Victoria Hospital in the U.K., applauded the country’s move.

“This is a significant moment for adults and children with the most difficult to treat epilepsies,” Thomas said. “NICE’s recommendation of cannabidiol oral solution follows a period of great anticipation and enthusiasm for patients and their clinicians. The European Medicines Agency licence and availability through the NHS is welcome as we badly need additional effective treatments for Dravet and LGS.”

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