The FDA will vote in June whether to approve the drug, The committee’s recommendation was delivered after reviewing data from the drug’s maker, GW Pharmaceuticals PLC, a UK-based biopharmaceutical company. “We’re obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex,” GW CEO Justin Gover said. Epidiolex was developed for severe, early-onset epilepsy syndromes, including Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life. It has also indication in Lennox-Gastaut syndrome, a type of epilepsy with multiple types of seizures. Tuberous sclerosis complex and infantile spasms, both of which begin in infancy and cause a sudden stiffening of the body, arms and legs with the head bent forward can be cured with Epidiolex. The drug proved to be effective.
“There have been side effects associated with it, and it appears a lot of the side effects were in conjunction with other medications, which is a concern, because most of those patients are on other medications,” Shauna Garris, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina’s Eshelman School of Pharmacy, explained. But this drug is a hope. It’s the first cannabis-based pharmaceutical to be approved by the FDA. It’s the first in a new class of treatments with a new mechanism of action against epilepsy.