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FDA Sends GW Pharma Drug Epidiolex To The Front Of The Line

By Brandon A. Dorfman
Dec 28, 2017

On Thursday GW Pharmaceuticals plc (NASDAQ:GWPH) announced that the recently submitted New Drug Application for Epidiolex was accepted for filing with Priority Review by the U.S. Food and Drug Administration. The drug, a CBD-based treatment, is designed for patients suffering from seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two conditions that stem from childhood epilepsy. FDA review of the Epidiolex NDA, as per the PDUFA (Prescription Drug User Fee Act), is expected to be completed by June 27, 2018.

The decision by the FDA bodes well for GW and Epidiolex, as only drugs that show real promise and that fill a void where no other treatment exists receive Priority Review Status. According to a statement put out by GW Pharma, Priority Review will speed up the review time for Epidiolex as compared to the typical standard review given to most drugs.

“We are pleased with the FDA’s acceptance of our NDA filing with Priority Review, an action that underscores the unmet need in the LGS and Dravet syndrome populations,” said GW CEO Justin Gover. “We look forward to working with the FDA during the review process to support the case for approval of Epidiolex to provide a much needed new treatment option for patients that suffer from these highly treatment-resistant conditions of childhood-onset epilepsy.”

Lennox-Gastaut Syndrome, or LGS, usually is seen in children between 3-5 years of age. It can have a variety of natural or outside causes, or, as is the case in 30 percent of sufferers, sometimes no reason can be found. Dravet syndrome occurs earlier, typically in the first year of life, and is associated with genetic causes. The latter currently has no FDA approved treatment.

With Epidiolex, a pharmaceutical formulation of purified cannabidiol, GW Pharma hopes to make a real breakthrough with these diseases and in the market. Already the company has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, as well as Fast Track Designation from the FDA for the treatment of Dravet syndrome.

Earlier this month, GW Pharma announced that they had ended the licensing agreement they once held with Otsuka Pharmaceutical Co., Ltd. over their other drug Sativex (nabiximols). At the closing bell, the stock was trading at $134.95, on higher than average trading volume. The company saw their price rises 28 percent this year, from a 52-week low of $92.65 to $140.52.

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