In a groundbreaking development, London-based GW Pharmaceuticals, just announced its brand new CBD drug application to the FDA…
The new drug, touted to be a billion-dollar cash cow for the company, integrates CBD for the “treatment of seizures associated with two specific types of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.”
Steve Schultz, a spokesperson from GW, said correctly that, “The submission is a significant event,” noting that the Epidiolex submission file contained thousands of documents, including preclinical and clinical information, as well as clinical data on 1,500 patients, 400 of whom have had more than a year of exposure to Epidiolex.
For their part, the FDA now has 60 days to either approve or fail the new medicine, with a view to having the product on the market by this time next year.
GW are hoping for big things form the new drug, due to what they say is “significant demand” from Lennox-Gastaut and Dravet patients populations.
Morgan Stanley analyst, Andrew S. Berens, wrote about the situation, “We expect focus will specifically be on anticipated drug-drug interaction (DDI) data expected at the meeting, as management anticipates presenting pooled data from the two Phase 3 LGS trials showing response rates at different thresholds and in the subgroups of patients with or without concomitant Onfi (clobazam).”
This raises some concerns about the connection between Clobazam and Epidiolex, but concerns that GW are not worried about in the slightest, “Our goal is to provide an additional option,” said the GW spokesperson, “We know that physicians and patients and parents of young patients desire to have a pharmaceutical medicine for the treatment of these seizures, especially these really challenging seizures.”[Image credit- Pixabay]