GW Pharma’s Epidiolex becomes first cannabis-based medicine available in US
pharmafile | June 26, 2018 | News story | Manufacturing and Production, Sales and Marketing | FDA, GW Pharma, Lennox-Gastaut syndrome, UK, US, cannabidiol, cannabis
In what could prove to be a pivotal decision, UK biotech GW Pharmaceuticals has announced that its oral cannabidiol solution Epidiolex has been awarded marketing approval in the US by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.
The news makes Epidiolex the first cannabis-derived medicine available in the US, amidst an ongoing and intensifying debate over the medical applications of the illegal substance, as well as its clinical availability. Despite the debate, Epidiolex contains less than 0.1% of tetrahydrocannabinol (THC), the psychoactive element which is the reason for the recreational use of cannabis.
Both LGS and Dravet syndrome are rare, severe forms of epilepsy which develop in childhood and can significantly impact day-to-day life, or even results in early death in a considerable number of cases. The conditions require multiple medications to manage and frequently prove treatment-resistant.
FDA Commissioner Scott Gottlieb commented: “This approval serves as a reminder that advancing sound development programmes that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And the FDA is committed to this kind of careful scientific research and drug development.”
It is hoped that the drug could be made available to children across the EU if the EMA follows suit when it comes to reviewing the drug later this year.
“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy. These children and their families face a long and challenging road and very few achieve adequate seizure control,” said Dr Elizabeth Thiele, Director of the Pediatric Epilepsy Program at Massachusetts General Hospital, Professor of Neurology at Harvard Medical School and a lead investigator in the Epidiolex clinical programme. “Based on numerous clinical trials, this medication may help meet the need for this specific pediatric patient population and is now the first to be approved by the FDA in Dravet syndrome.”
GW’s CEO Justin Gover also commented: “Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies, This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
Matt Fellows
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