The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA unanimously recommended supporting the approval of the NDA from GW Pharmaceuticals (NASDAQ:GWPH) and its U.S. subsidiary Greenwich Biosciences, for the cannabidiol oral solution (CBD), Epidiolex, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older.
If approved, Epidiolex would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs. If approved, Epidiolex would be the first-ever FDA-approved medicine for Dravet syndrome patients.
During the meeting, the company presented the results of a robust clinical development program that included three Phase 3 clinical trials and an open label extension study. In the Phase 3 studies, Epidiolex added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
“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,” GW CEO, Justin Gover, said in a statement.
“We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA,” he added. The PDUFA date for completion of the NDA review is June 27.
