GW Pharmaceuticals Inc. (GWPH) continues to get closer and closer to FDA approval of its drug Epidiolex for the rare forms of epilepsy Lennox-Gastaut and Dravet Syndrome. Epidiolex is GW’s lead cannabinoid product candidate and is a pharmaceutical formulation of purified cannabidiol or CBD.
Following a live hearing on Thursday, the company announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended supporting the approval of the New Drug Application (NDA) for the investigational cannabidiol oral solution (CBD) for treatment in patients two years old and up.
“We are pleased by the Advisory Committee’s unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy,” said Justin Gover, GW’s Chief Executive Officer. “This favorable outcome marks an important milestone in our company’s unwavering commitment to address the significant unmet need for patients with LGS and Dravet syndrome and our resolve to study Epidiolex under the highest research and manufacturing standards. We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA.”
Today’s recommendation doesn’t mean that the FDA will definitely approve it, but it is a positive sign. The FDA Advisory Committees is an independent expert panel. Their votes are not binding but are considered by the FDA when deciding whether to approve a new medicine. The next event for GW Pharma is June 27 which is the goal date for PDUFA (Prescription Drug User Fee Act) completion of the NDA review of the cannabidiol oral solution and if approved, the medicine is expected to be available by prescription in the second half of 2018.
“GW Pharmaceuticals’ efforts and success with Epidiolex proves several important facts on several fronts. I believe the most important is this… to refer to a product as ‘medicine,’ the time-tested process of clearing a new therapeutic treatment through the FDA is sacrosanct and essential to making that claim. Congratulations to GW Pharmaceuticals for finishing that race,” said Dean Petkanas, CEO of Kannalife Sciences.
GW has also submitted a Marketing Authorization Application to the European Medicines Agency with an expected decision date in early 2019.
GW Pharmaceuticals stock was lately trading at $134. The stock popped earlier this week upon positive comments about Epidiolex.