FDA seeks more data on Intercept's obeticholic acid in NASH, delaying AdCom

Intercept Pharmaceuticals said Friday that the FDA postponed an advisory committee meeting tentatively scheduled for June 9 to discuss the marketing application for obeticholic acid (OCA) as a potential treatment of liver fibrosis due to non-alcoholic steatohepatitis (NASH). The company noted that the delay to the meeting, which had already been pushed back from its original date in April due to the COVID-19 pandemic, will allow the agency to review additional data that it has requested.

"While this delay was unanticipated, following our most recent dialogue with the FDA we believe that the additional data being submitted will be important in facilitating a more informed discussion at the AdCom," remarked CEO Mark Pruzanski. Intercept, whose shares fell as much as 15% on the news, indicated that it intends to submit the new data within the next week, but did not provide more details.


Decision deadline likely pushed back

The company indicated that the FDA will propose a new date for the advisory committee meeting in the "near future," adding however that it now expects the previous, already-extended June 26 target action date for the filing to also be deferred. Intercept's application is supported by data from the pivotal Phase III REGENERATE trial, showing that once-daily OCA met the primary endpoint of fibrosis improvement of at least one stage or more, with no worsening of NASH, in 23.1% of patients compared to 11.7% for placebo at the planned 18-month interim analysis.

The drug, a farnesoid X receptor agonist, is already approved in the US under the name Ocaliva to treat certain patients with primary biliary cholangitis. For related analysis, see ViewPoints: ICER analysis suggests Intercept could be on target.

Meanwhile, earlier this month, Genfit reported interim data from the Phase III RESOLVE-IT trial indicating that its experimental dual PPAR agonist elafibranor did not have a significant effect on the primary endpoint of NASH resolution without worsening of fibrosis in the intent-to-treat population (for related analysis, see ViewPoints: Genfit, CymaBay and Intercept demonstrate shifting sands in NASH).

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