FDA panel unanimously votes for GW Pharma's cannabis-derived epilepsy drug

Henrietta Strickland
April 20, 2018

As it turns out, GW Pharma won an FDA approval for its cannabis drug.

GW Pharmaceuticals offered "substantial evidence" to back Epidiolex's effectiveness, according to the FDA panel's report.

US drug regulators are edging closer to approving the first-ever medicine derived from a marijuana plant, an experimental epilepsy treatment developed by GW Pharmaceuticals Plc. It is meant to treat severe seizures in children caused by rare forms of epilepsy called Lennox-Gastaut and Dravet syndromes. "We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA".

"This is clearly a breakthrough drug for an very bad disease", said panel member Dr. John Mendelson, of the Friends Research Institute in Baltimore. Their votes are not binding but are considered by the FDA when deciding whether to approve a new medicine. If approved, it would take down the mantle of the country's first cannabis-derived drug.

The 13-member FDA panel voted unanimously in favor of the experimental medication made from a chemical found in cannabis - one that does not get users high. In the briefing documents, the FDA officials wrote that the "risk of liver injury has the potential to be serious", but that it could be addressed by tracking liver function during treatment. Epidiolex - which contains cannabidiol (CBD), rather than the psychoactive component of cannabis, THC - is intended for seizures associated with two rare types of childhood epilepsy.

As per its website, GW Pharmaceuticals is working on a bevy of other cannabinoid-derived drugs to treat a host of ailments including autism, schizophrenia, and nasty cancers like glioblastomas.

But after receiving Epidiolex, "her seizures went from 40 to 50 a day to only a few or none per week", said Carlin, whose travel was paid for by GW.

Cannabis's value in treating seizures is responsible for its growing acceptance as legitimate medicine across the United States.

CBD oil is now sold online and in specialty shops across the country, though its legal status remains murky. "America clearly is moving, more so, and embracing cannabis as something that can be used medicinally".

Vridian expects to see additional cannabis-cased drug candidates introduced by companies for a variety of indications, Phillips said. Wall Street analysts estimate it could cost more than $25,000 per year.

Other reports by Click Lancashire

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