GW Pharma’s Epidiolex becomes first cannabis-based medicine to be made available in United States
pharmafile | November 2, 2018 | News story | Medical Communications | Epidiolex, GW Pharma, Medical marijuana, cannabidiol, cannabis
GW Pharma’s Epidiolex has become the first plant-derived, cannabis-based medicine to be made available on prescription in all 50 US states. The medication consists of highly-purified, plant-derived cannabidiol (CBD).
The twice daily oral solution was approved by the FDA for the treatment of seizures associated with either Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients aged 2 years and older in June of this year; however the CBD based drug will now be available to patients across the United States.
“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures,” said Justin Gover, CEO of GW Pharmaceuticals, the maker of Epidiolex, in a written statement. “We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”
Although Epidiolex will cost roughly $32,500 a year, the company has introduced a comprehensive patient support programme aimed at increasing access and reducing out-of-pocket costs.
GW Pharma has also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA). The company expects a decision to be made in the first quarter of 2019.
“Epidiolex is a much-needed new treatment option for patients with LGS, a rare and severe form of childhood-onset epilepsy that typically persists into adulthood,” Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation, commented. “Despite the use of multiple epilepsy treatments, the majority of LGS patients continue to have life-long, debilitating seizures and our community welcomes the availability of a new, first-in-class treatment option.”
Louis Goss
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