Epidiolex Enjoys Mellow Advisory Cmte. Meeting
GW Pharmaceuticals’ cannabis-derived epilepsy drug gets unanimous panel endorsement, affirming US FDA's belief that there are no obstacles to approval.
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Lead pharmacology/toxicology reviewer said Epdiolex was not approvable because of inadequate assessment of 7-COOH-CBD human metabolite, but supervisor said it could be conducted in postmarketing phase because of the unmet need the drug fills.
Highly unusual move of an ODE director leading clinical review of a drug had nothing to do with public sentiment regarding Epidiolex's derivation from marijuana, US FDA says; Unger instead wanted to use the review as an example for future reviews to rely more on the agency's analyses rather than those of applicants.
The approval for the GW Pharmaceuticals drug covers the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two forms of rare and severe childhood epilepsy – the US agency was quick to clarify what the approval did not cover, chiefly marijuana.