GW Pharmaceuticals plc (GWPH) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Epidiolex, an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018.
The priority review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapies exist. LGS and Dravet are two rare and difficult to treat conditions of childhood-onset epilepsy. Patients with LGS typically suffer from multiple seizures, which frequently lead to falls and injuries. Resistance to anti-epileptic drugs is common in patients with LGS. The granting of priority review for the Epidiolex NDA accelerates the timing of the FDA review of the application compared to a standard review.
In GW’s statement, the company said that the FDA has stated in its acceptance letter that it is currently planning to hold an advisory committee meeting to discuss this application. Epidiolex uses a pharmaceutical form of purified cannabidiol or CBD. The cannabis plant from which the CBD is derived from is currently listed as a schedule one drug meaning it has no medicinal qualities. Yet, the FDA could still approve Epidiolex even as it remains listed as a controlled substance.
“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 Justin Gover, GW’s Chief Executive Officer. “We look forward to working with the FDA during the review process to support the case for approval of Epidiolex so as to provide a much needed new treatment option for patients that suffer from these highly treatment-resistant conditions of childhood-onset epilepsy.”
Dravet Syndrome usually appears during the first year of life in previously healthy and developmentally normal infants. The initial seizures are often body temperature related, severe, and long-lasting. There are currently no FDA-approved treatments and nearly all patients continue to experience seizures and other medical needs throughout their lifetime.
To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome and LGS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA.
GW Pharmaceuticals revenue has climbed 28% year over year. The stock has risen from a 52-week low of $92.65 to $140.52 and was lately trading at $136.40. Goldman Sachs recently upgraded the stock to a buy.