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.
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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.
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