FDA Approves Epidiolex for New Condition That Causes Benign Tumors, Seizures

On Friday, the US Food and Drug Administration approved Epidiolex, an oral cannabidiol solution, to treat seizures associated with the condition tuberous sclerosis complex in patients one year or older. 

In 2018, the British company GW Pharmaceuticals, maker of Epidiolex, became the first in the United States to obtain approval from the US FDA for a product derived directly from cannabis plants. The approval was granted to treat patients with rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. 

Now, the FDA has approved, through Priority Review, GW Pharmaceuticals’ application, via its US subsidiary Greenwich Biosciences, for Epidiolex to treat tuberous sclerosis complex, a rare genetic condition affecting 1 in 6,000 people that causes benign tumors to grow in areas including the brain, eyes, lungs, and heart. The condition also affects the central nervous system, and can cause a number of debilitating effects, including seizures, though symptom severity varies from patient to patient. 

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” Douglas Throckmorton, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement on Friday. 

“The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

A randomized, double-blind, placebo-controlled trial of 224 patients with tuberous sclerosis  showed that the patients that received Epidiolex, rather than a placebo, had a “significantly greater reduction in the frequency of seizures.”

Epidiolex also achieved another first for a cannabis-derived pharmaceutical in April: total descheduling by the US Drug Enforcement Administration, meaning it is off the list of controlled substances and no longer under the agency’s purview. 

“This notification from DEA fully establishes that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” GW Pharmaceuticals CEO Justin Gover said in a statement at the time. “We would like to thank DEA for confirming the non-controlled status of this medicine.”

GW Pharmaceuticals’ subsidiary Greenwich Biosciences has been lobbying in all fifty US states, as Cannabis Wire first reported. Additionally, when it came to federal lobbying last year, Greenwich outspent every other cannabis company or organization, according to a Cannabis Wire analysis of disclosure reports. 

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