While there is broad agreement that the 19 May US Food and Drug Administration advisory panel’s lopsided votes against recommending approval of Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) for non-alcoholic steatohepatitis was a blow for that company, opinion is more varied about whether the Gastrointestinal Drugs Advisory Committee’s tight focus on safety and the clinical meaningfulness of meeting the surrogate efficacy endpoints will read through to other NASH drug candidates and their sponsors.
The committee voted 12-2 (with two abstentions) that Intercept’s drug – an oral FXR agonist now in its second FDA review cycle – did not demonstrate efficacy that outweighs the risks in treating NASH patients with pre-cirrhotic (F2 or F3) fibrosis scores. (Also see "Intercept’s OCA Facing Extended Approval Wait In NASH As Known Risks Swamp Uncertain Benefits" - Pink Sheet, 20 May, 2023
KEY TAKEAWAYS
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OCA is the first drug to be reviewed for NASH, and the first test case of the surrogate endpoints FDA established in its NASH guidance.
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The panelists agreed with FDA reviewers’ assessment the efficacy was modest and safety concerns, chiefly drug-induced liver injury, led to a recommendation against accelerated approval
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