The FDA Unanimously Recommends First Cannabinoid Treatment for Epilepsy

GW Pharmaceuticals has received a unanimous recommendation from the FDA Advisory Committee Meeting supporting the approval of what could soon be the first cannabinoid-based drug, to treat seizures in two severe forms of epilepsy. 

The FDA may soon approve the first medicine based on a cannabinoid to treat two rare and severe forms of epilepsy. An FDA committee specialized in drugs for the nervous system has unanimously recommended that the FDA approves Epidiolex, a cannabinoid-based drug developed by the British company GW Pharmaceuticals. It is a rare feat that the 13 experts agree to recommend a new treatment.

Epidiolex is an oral purified solution of cannabidiol — one of the hundreds of cannabinoid compounds found in cannabis plants. The drug has shown to reduce the frequency of epileptic seizures in patients as young as 2 years old with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. According to GW, more than 90% of patients with these rare forms of epilepsy have multiple seizures a day, and many do not respond to standard epilepsy treatments.

Analysts have predicted that Epidiolex has a potential to become a blockbuster, with sales expected to reach from close to $1Bn to up to $2Bn.


Image via Vladkk /Shutterstock

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  • Quincy Fortier

    I think two years of exclusivity and then open source.