FDA accepts NDA filing for Epidiolex in the treatment of Lennox-Gastaut syndrome and Dravet syndrome

The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is 27 June 2018.

In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.

“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.”

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.

Epidiolex is a pharmaceutical formulation of purified cannabidiol, which is in development for the treatment of several rare childhood-onset epilepsy disorders. GW has submitted an NDA with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome with an expected approval and launch in 2018.

To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, TSC and IS. In addition, 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. The company has also received Orphan Designation from the EMA for Epidiolex for the treatment of LGS, Dravet syndrome, West syndrome and TSC. GW is currently evaluating additional clinical development programs in other orphan seizure disorders including Phase III trials in Tuberous Sclerosis Complex and Infantile Spasms.