GW Pharmaceutocals (GWPH) announced that the U.S. FDA accepted its recently submitted New Drug Application (NDA) for Epidiolex (cannabidiol or CBD), an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy.
The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018.
Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapies exist. 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 its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.
Epidiolex would be the first FDA approved drug that uses CBD, a compound found in cannabis, which is considered Schedule I illegal drug by the Federal government.
Today's news was as expected. The company is preparing for a commercial launch in the US next year and hopes to hear back from European regulators in early 2019.
GW Pharma raised $276 millin an offering earlier this month and the stock hit a new all-time high this week.
GW Pharma is based in the UK and has a market cap just below $4 billion.