Epidiolex May Have Avoided CRL Over Metabolite Assessment Due To Unmet Need
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.
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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.
GW Pharmaceuticals’ cannabis-derived epilepsy drug gets unanimous panel endorsement, affirming US FDA's belief that there are no obstacles to approval.
Epidiolex Advisory Committee Appears To Be Covering US FDA's Bases, But Liver Injury Concerns Persist
Panel for first-ever marijuana derivative will discuss safety issues, including link to transaminase elevations, but low potential for abuse and strong efficacy suggest a smooth route to approval.