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GW Pharmaceuticals plc (GWPH) continues to deliver...
Today, GW along with its subsidiary Greenwich Biosciences, completed the rolling submission of a New Drug Application (NDA) to the FDA for Epidiolex as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy.
GW has received Rare Pediatric Disease and Orphan Drug Designations from the FDA for Epidiolex in the treatment of both LGS and Dravet syndrome. Additionally, GW has received Fast Track Designation from the FDA for Epidiolex for the treatment of Dravet syndrome.
The NDA for Epidiolex is supported by data from three Phase 3 safety and efficacy studies, each of which met their primary endpoint. Epidiolex was generally well tolerated in these trials. The NDA includes safety data on approximately 1,500 patients, with approximately 400 patients on continuous therapy for more than one year. Beyond pivotal safety and efficacy data, the NDA includes a comprehensive clinical pharmacology, pre-clinical and toxicology package. The CMC section of the NDA incorporates the Company’s recently expanded UK manufacturing facilities.
GW plans to file a Marketing Authorization Application (MAA) in Europe for Epidiolex soon.
From the CEO
GW Pharmaceuticals CEO Justin Gover, CEO said, “The submission of the Epidiolex NDA is an important milestone for patients with LGS and Dravet syndrome in that a potential new treatment option is within sight for these very difficult to treat and devastating conditions," stated. “On behalf of all those patients, clinicians and GW employees who have supported the Epidiolex program, we are pleased to submit this promising therapy for FDA review and we look forward to working with the FDA throughout the review process. This regulatory submission is a demonstration of GW’s commitment to developing innovative cannabinoid-based treatments that have the potential to address significant unmet medical needs.”
Owns a Pipeline of Products that are in Advanced Clinical Trials
GW has by far, the most advanced pipeline of cannabis-derived products and this should create catalysts for years to come.
The cannabis biotech firm is changing the landscape of the biotech industry and the company already sells a cannabis-derived treatment for multiple sclerosis is 27 countries. GW is a company that investors need to watch as it continues to execute on its pipeline and create value for shareholders.
This is positive development for GW and we will monitor how the market responds to this update. We expect to see GWPH trade higher off this news and will keep an eye on how the shares move from here.