FDA Grants GW Pharmaceuticals Priority Review For Cannabidiol Drug In Seizure Condition

A drug from GW Pharmaceuticals plc GWPH targeting a cause of genetic epilepsy has received Priority Review status from the U.S. Food and Drug Administration. 

The Cambridge, U.K.-based company and its subsidiary Greenwich Biosciences Inc. confirmed Tuesday that their new drug application for the use of Epidiolex — cannabidiol — CV will have a review time of about six months instead of the FDA's typical 10. 

This status is usually granted to therapeutics that have the potential of treating an illness that doesn’t have an existing therapy. 

The GW drug is focused on treating seizures related to Tuberous Sclerosis Complex, or TSC, a rare genetic condition that causes the development of usually benign tumors in vital organs. It's considered a primary cause of genetic epilepsy, according to the company. 

Per the Prescription Drug User Fee Act, the FDA review of the EPIDIOLEX supplemental new drug application has a goal finalization date of July 31, according to GW.

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Epidiolex oral solution, CV, has already been authorized for treating seizures connected with two rare forms of childhood-onset epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome.

“We are pleased with the FDA’s acceptance of our EPIDIOLEX sNDA filing with Priority Review, an action that underscores the unmet need for new treatment options for patients with TSC, a rare and severe childhood-onset disease,” GW Chief Executive Officer Justin Gover said in a statement.

More than 60% of individuals with TSC do not achieve seizure control with standard anti-epileptic drug treatments, he said. 

"Today’s news is therefore important for TSC patients and their clinicians, and we look forward to working with the FDA during the review process to expand the EPIDIOLEX product label for use in TSC,” he added.

GW Pharma shares were trading 0.33% higher at $87.86 at the time of publication Wednesday.

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Photo courtesy of GW Pharmaceuticals.