Posted by Michael Wonder on 04 Feb 2020
GW Pharmaceuticals and Greenwich Biosciences submit supplemental new drug application to U.S. FDA for Epidiolex (cannabidiol) for the treatment of tuberous sclerosis complex
3 February 2020 - GW Pharmaceuticals announced today that it has submitted a supplemental new drug application to the U.S. FDA for Epidiolex (cannabidiol) oral solution.
The application seeks to expand the Epidiolex label to include the treatment of seizures associated with tuberous sclerosis complex, a rare genetic condition.
The application is supported by data from a Phase 3 safety and efficacy study, results of which were recently presented at the American Epilepsy Society 2019 annual meeting.
